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INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial (ACDF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00485173
Recruitment Status : Completed
First Posted : June 12, 2007
Results First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Degenerative Disc Disease
Intervention Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
Enrollment 224
Recruitment Details Five subjects in investigational group and 4 subjects in control group died within 24 months postoperatively. Among them, however, one investigational subject who died at 20 months and one control subject who died at 23 months reported some data that were included as the 24-month evaluation. Thus, they were counted as evaluated at 24 months.
Pre-assignment Details  
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate. Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Period Title: Overall Study
Started 224 486
Completed 188 [1] 422 [1]
Not Completed 36 64
Reason Not Completed
Death             4             3
Lost to Follow-up             32             61
[1]
The number of completed participants is reported the number of subjects who had any 24-month data.
Arm/Group Title INFUSE® Bone Graft Historical Control Total
Hide Arm/Group Description In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate. Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190). Total of all reporting groups
Overall Number of Baseline Participants 224 486 710
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 224 participants 486 participants 710 participants
46.8  (10.2) 44.2  (8.7) 45.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Female
118
  52.7%
251
  51.6%
369
  52.0%
Male
106
  47.3%
235
  48.4%
341
  48.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Caucasian 198 447 645
Black 20 18 38
Asian 2 4 6
Hispanic 3 13 16
Other 1 4 5
Height  
Mean (Standard Deviation)
Unit of measure:  In.
Number Analyzed 224 participants 486 participants 710 participants
67.5  (4.2) 67.5  (4.0) 67.5  (4.1)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs.
Number Analyzed 224 participants 486 participants 710 participants
188.8  (43.6) 182.5  (40.4) 184.5  (41.5)
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Single 30 61 91
Married 163 373 536
Divorced 21 44 65
Separated 7 4 11
Widowed 3 4 7
Education Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
< high School 10 29 39
High School 80 142 222
> high School 134 314 448
Worker's Compensation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Yes 5 46 51
No 219 440 659
Unresolved Spinal Litigation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Yes 28 38 66
No 196 448 644
Tobacco Used  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Yes 66 145 211
No 157 341 498
Alcohol Used  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Yes 111 150 261
No 113 336 449
Preop Work Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 486 participants 710 participants
Yes 153 309 462
No 71 176 247
1.Primary Outcome
Title Rate of Overall Success
Hide Description

Rate of overall success is reported as the percentage of participants who met all of the following criteria:

  1. fusion at the treated level;
  2. pain/disability (Neck Disability Index) success;
  3. neurological status success;
  4. no serious adverse event classified as “implant associated” or “implant/surgical procedure associated;”
  5. no additional surgical procedure classified as a “failure.”
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 162 352
Measure Type: Number
Unit of Measure: percentage of participants
80.9 59.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
2.Secondary Outcome
Title Success Rate of Fusion
Hide Description

Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:

  1. Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.
  2. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
  3. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 160 345
Measure Type: Number
Unit of Measure: percentage of participants
99.4 87.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Success Rate of Neck Disability Index
Hide Description Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 413
Measure Type: Number
Unit of Measure: percentage of participants
85.8 79.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
4.Secondary Outcome
Title Success Rate of Neurological Status
Hide Description Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 177 414
Measure Type: Number
Unit of Measure: percentage of participants
93.8 85.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Neck Pain Success Rate
Hide Description Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 175 413
Measure Type: Number
Unit of Measure: percentage of participants
96.0 92.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value 0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
6.Secondary Outcome
Title Arm Pain Success Rate
Hide Description Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 175 413
Measure Type: Number
Unit of Measure: percentage of participants
90.9 88.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
7.Secondary Outcome
Title Success Rate of SF-36 PCS
Hide Description Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 407
Measure Type: Number
Unit of Measure: percentage of participants
89.8 88.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value 0.003
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.466
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
8.Secondary Outcome
Title Success Rate of SF-36 MCS
Hide Description Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 407
Measure Type: Number
Unit of Measure: percentage of participants
75.0 71.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The predefined non-inferiority margin was 0.10.
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Superiority analysis was performed if non-inferiority was demonstrated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.
Method Regression, Logistic
Comments [Not Specified]
9.Secondary Outcome
Title Operative Time
Hide Description Operative time was recorded from skin incision to wound closure.
Time Frame Time of operation, approximately 1.5 hrs.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 224 486
Mean (Standard Deviation)
Unit of Measure: hrs
1.0  (0.5) 1.4  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Blood Loss
Hide Description [Not Specified]
Time Frame During the time of operation, approximately 1.5 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 224 484
Mean (Standard Deviation)
Unit of Measure: ml
40.1  (54.1) 58.4  (59.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title Hospital Stay
Hide Description [Not Specified]
Time Frame During the time of hospital stay, average of 1 day.
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 224 486
Mean (Standard Deviation)
Unit of Measure: days
1.0  (0.7) 1.0  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.341
Comments P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Number of Patients Who Had Secondary Surgeries at the Index Level
Hide Description Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 224 486
Measure Type: Number
Unit of Measure: participants
6 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.479
Comments P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.
Method Regression, Cox
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Neck Disability Index Score
Hide Description The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 413
Mean (Standard Deviation)
Unit of Measure: units on a scale
NDI at baseline 50.2  (14.3) 53.5  (16.2)
NDI at 24 months 14.6  (17.1) 20.9  (16.0)
NDI change at 24 months from baseline -34.9  (17.3) -32.3  (20.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
14.Other Pre-specified Outcome
Title Neck Pain Score
Hide Description Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score is the sum of pain intensity and frequency scores.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 175 413
Mean (Standard Deviation)
Unit of Measure: units on a scale
Neck pain at baseline 15.9  (2.7) 15.8  (3.8)
Neck pain at 24 months 4.5  (5.2) 6.0  (6.9)
Neck pain change at 24 months from baseline -11.2  (5.3) -9.8  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
15.Other Pre-specified Outcome
Title Arm Pain Score
Hide Description Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score will be the sum of pain intensity and frequency scores.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 175 413
Mean (Standard Deviation)
Unit of Measure: units on a scale
Arm pain at baseline 13.5  (5.1) 14.8  (4.7)
Arm pain at 24 months 3.6  (4.9) 4.7  (5.8)
Arm pain change at 24 months from baseline -10.1  (6.3) -10.1  (6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
16.Other Pre-specified Outcome
Title General Health Status -- SF-36 PCS
Hide Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 407
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 PCS at baseline 31.6  (6.6) 31.9  (7.3)
SF-36 PCS at 24 months 47.7  (11.1) 45.3  (11.5)
SF-36 PCS change at 24 months from baseline 15.6  (10.9) 13.1  (11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
17.Other Pre-specified Outcome
Title General Health Status -- SF-36 MCS
Hide Description The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 176 407
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 MCS at baseline 43.6  (12.0) 43.6  (12.1)
SF-36 MCS at 24 months 51.8  (9.5) 50.9  (10.8)
SF-36 MCS Change at 24 months from baseline 8.0  (12.0) 7.2  (13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.189
Comments P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.
Method ANCOVA
Comments [Not Specified]
18.Other Pre-specified Outcome
Title Ossification in the Region of Target Level
Hide Description Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.
Time Frame 24 months post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
Primary dataset.
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description:
In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
Overall Number of Participants Analyzed 224 486
Measure Type: Number
Unit of Measure: percentage of participants
Preoperative (n=220, 442) 40.9 36.9
24 months (n=168, 407) 78.6 59.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection INFUSE® Bone Graft, Historical Control
Comments Statistical analysis at 24 months postoperation.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.
Method Regression, Logistic
Comments [Not Specified]
Time Frame Up to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title INFUSE® Bone Graft Historical Control
Hide Arm/Group Description In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate. Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
All-Cause Mortality
INFUSE® Bone Graft Historical Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
INFUSE® Bone Graft Historical Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/224 (31.70%)      159/486 (32.72%)    
Cardiac disorders     
Acute Myoccardial Infarction * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Angina Pectoris * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Atrial Fibrillation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Atrial Flutter * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Cardiac Arrest * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Cardiogenic Shock * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Cardiomegaly * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Coronary Artery Disease * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Myocardial Infarction * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Palpitations * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Supraventricular Extrasystoles * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Ventricular Extrasystoles * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Endocrine disorders     
Autoimmune Thyroiditis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hypothyroidism * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Thyroid Cyst * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Eye disorders     
Astigmatism * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Cataract * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Ectropion * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Lacrimation Increased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Visual Impairment * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gastrointestinal disorders     
Abdominal Distension * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Abdominal Hernia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Abdominal Pain * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Abdominal Pain Upper * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Crohn's Disease * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Diarrhoea * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Dysphagia * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Gastrointestinal Ulcer * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Haematochezia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haemorrhoids * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hiatus Hernia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Ileus * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Inguinal Hernia * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Intestinal Perforation * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Irritable Bowel Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Nausea * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Oesophageal Fistula * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Proctalgia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Small Intestinal Obstruction * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Umbilical Hernia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Vomiting * 1  3/224 (1.34%)  3 2/486 (0.41%)  2
General disorders     
Accidental Death * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Adverse Drug Reaction * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Asthenia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Axillary Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Chest Discomfort * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Chest Pain * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Device Breakage * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Drug Withdrawal Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Facial Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gait Disturbance * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Hernia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Local Swelling * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Non-Cardiac Chest Pain * 1  3/224 (1.34%)  3 0/486 (0.00%)  0
Oedema Peripheral * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pain * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Pyrexia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Soft Tissue Inflammation * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Spinal Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hepatobiliary disorders     
Cholelithiasis * 1  3/224 (1.34%)  3 1/486 (0.21%)  1
Gallbladder Disorder * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Hepatomegaly * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Immune system disorders     
Drug Hypersensitivity * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hypersensitivity * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Immunodeficiency Common Variable * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Sarcoidosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Infections and infestations     
Bacterial Sepsis * 1  1/224 (0.45%)  2 0/486 (0.00%)  0
Extradural Abscess * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Kidney Infection * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Meningitis Herpes * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Paraoesophageal Abscess * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pneumonia Primary Atypical * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Postoperative Wound Infection * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Pyelonephritis * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Respiratory Tract Infection * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Sepsis * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Staphylococcal Sepsis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Urinary Tract Infection * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Wound Infection * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Injury, poisoning and procedural complications     
Accident At Work * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Bone Fragmentation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Concussion * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Epidural Fibrosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Eye Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Fall * 1  4/224 (1.79%)  5 6/486 (1.23%)  6
Gastrointestinal Anastomotic Leak * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Intervertebral Disc Injury * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Joint Injury * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Laceration * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Ligament Rupture * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Lumbar Vertebral Fracture * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Meniscus Lesion * 1  2/224 (0.89%)  2 4/486 (0.82%)  4
Multiple Drug Overdose Accidental * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Nerve Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Post Laminectomy Syndrome * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Post Procedural Haematoma * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Post Procedural Haemorrhage * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Post-Traumatic Neck Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Procedural Haemorrhage * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Procedural Headache * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pseudomeningocele * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pubis Fracture * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Road Traffic Accident * 1  6/224 (2.68%)  6 5/486 (1.03%)  5
Spinal Compression Fracture * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Tendon Rupture * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Tracheal Deviation * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Investigations     
Hepatic Enzyme Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pancreatic Enzymes Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
White Blood Cell Count Increased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hypokalaemia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hyponatraemia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/224 (0.45%)  1 2/486 (0.41%)  4
Arthropathy * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Back Pain * 1  6/224 (2.68%)  6 8/486 (1.65%)  8
Bursitis * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Cervical Spinal Stenosis * 1  2/224 (0.89%)  2 15/486 (3.09%)  15
Chondromalacia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Compartment Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Exostosis * 1  2/224 (0.89%)  2 12/486 (2.47%)  16
Facet Joint Syndrome * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Fibromyalgia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Flank Pain * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Intervertebral Disc Degeneration * 1  9/224 (4.02%)  9 18/486 (3.70%)  18
Intervertebral Disc Disorder * 1  4/224 (1.79%)  4 4/486 (0.82%)  4
Intervertebral Disc Protrusion * 1  15/224 (6.70%)  15 32/486 (6.58%)  35
Intervertebral Disc Space Narrowing * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Joint Crepitation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Joint Range Of Motion Decreased * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Kyphosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Ligament Disorder * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Limb Discomfort * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Lumbar Spinal Stenosis * 1  4/224 (1.79%)  4 10/486 (2.06%)  10
Monarthritis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Muscle Spasms * 1  1/224 (0.45%)  1 4/486 (0.82%)  4
Muscle Tightness * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Muscle Twitching * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Muscular Weakness * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Musculoskeletal Chest Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Musculoskeletal Discomfort * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Musculoskeletal Pain * 1  3/224 (1.34%)  3 11/486 (2.26%)  13
Myalgia * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Neck Pain * 1  6/224 (2.68%)  7 16/486 (3.29%)  18
Osteoarthritis * 1  3/224 (1.34%)  5 2/486 (0.41%)  2
Pain In Extremity * 1  2/224 (0.89%)  2 9/486 (1.85%)  9
Pseudarthrosis * 1  2/224 (0.89%)  2 16/486 (3.29%)  16
Rheumatoid Arthritis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Rotator Cuff Syndrome * 1  5/224 (2.23%)  6 11/486 (2.26%)  12
Scoliosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Spinal Column Stenosis * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Spinal Osteoarthritis * 1  5/224 (2.23%)  5 8/486 (1.65%)  8
Spondylolisthesis * 1  4/224 (1.79%)  4 1/486 (0.21%)  1
Synovial Cyst * 1  1/224 (0.45%)  1 1/486 (0.21%)  2
Tendon Disorder * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Trigger Finger * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Vertebral Foraminal Stenosis * 1  5/224 (2.23%)  5 4/486 (0.82%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain Neoplasm * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Fibrous Histiocytoma * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Myolipoma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Prostate Cancer * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Skin Cancer * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Thyroid Adenoma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Nervous system disorders     
Amnesia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Arachnoid Cyst * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Burning Sensation * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Carpal Tunnel Syndrome * 1  2/224 (0.89%)  2 10/486 (2.06%)  10
Cerebrovascular Accident * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Cervical Cord Compression * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Cervicobrachial Syndrome * 1  0/224 (0.00%)  0 7/486 (1.44%)  7
Convulsion * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Dizziness * 1  0/224 (0.00%)  0 1/486 (0.21%)  2
Dysaesthesia * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Dyskinesia * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Headache * 1  3/224 (1.34%)  3 5/486 (1.03%)  5
Hypoaesthesia * 1  1/224 (0.45%)  1 8/486 (1.65%)  9
Hypokinesia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hypoxic-Ischaemic Encephalopathy * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Loss Of Consciousness * 1  3/224 (1.34%)  3 1/486 (0.21%)  1
Lumbar Radiculopathy * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Migraine * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Myelitis Transverse * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Myelopathy * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Nerve Root Compression * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Paraesthesia * 1  2/224 (0.89%)  2 4/486 (0.82%)  4
Perineurial Cyst * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Radicular Pain * 1  0/224 (0.00%)  0 7/486 (1.44%)  7
Radiculopathy * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Sciatica * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Sensory Loss * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Spinal Cord Compression * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Spinal Cord Ischaemia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Spinal Cord Oedema * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Syncope * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Thoracic Outlet Syndrome * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Tremor * 1  0/224 (0.00%)  0 1/486 (0.21%)  2
Ulnar Nerve Palsy * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pregnancy, puerperium and perinatal conditions     
Foetal Hypokinesia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Premature Labour * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Psychiatric disorders     
Abnormal Behaviour * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Alcohol Abuse * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Anxiety * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Depression * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Schizophrenia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Stress * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Suicidal Behaviour * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Renal and urinary disorders     
Calculus Ureteric * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Cystitis Interstitial * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hydronephrosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Nephrolithiasis * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Neurogenic Bladder * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Urinary Incontinence * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Endometriosis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Menorrhagia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Prostatitis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Prostatomegaly * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Scrotal Pain * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Testicular Torsion * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Foreign Body Aspiration * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Haemoptysis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pharyngeal Haematoma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Pleural Effusion * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pneumothorax * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pulmonary Embolism * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pulmonary Sarcoidosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Sleep Apnoea Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Throat Irritation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Vocal Cord Polyp * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Keloid Scar * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Surgical and medical procedures     
Face Lift * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gastric Bypass * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Tonsillectomy * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Venous Operation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Vascular disorders     
Aortic Aneurysm * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Aortic Stenosis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Deep Vein Thrombosis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haematoma * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Hypertension * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hypotension * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Orthostatic Hypertension * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Peripheral Artery Aneurysm * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Thrombophlebitis Superficial * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INFUSE® Bone Graft Historical Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   186/224 (83.04%)      371/486 (76.34%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/224 (0.45%)  2 0/486 (0.00%)  0
Leukocytosis * 1  4/224 (1.79%)  4 1/486 (0.21%)  1
Lymph Node Pain * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Lymphadenopathy * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Splenomegaly * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Cardiac disorders     
Arrhythmia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Atrial Fibrillation * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Bradycardia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Coronary Artery Disease * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Mitral Valve Incompetence * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Palpitations * 1  0/224 (0.00%)  0 5/486 (1.03%)  5
Sinus Bradycardia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Sinus Tachycardia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Supraventricular Extrasystoles * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Ventricular Extrasystoles * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Ear and labyrinth disorders     
Deafness * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Ear Pain * 1  4/224 (1.79%)  4 0/486 (0.00%)  0
Hearing Impaired * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hyperacusis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Tinnitus * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Vertigo * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Vestibular Disorder * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Endocrine disorders     
Autoimmune Thyroiditis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Goitre * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hyperthyroidism * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hypothyroidism * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Eye disorders     
Astigmatism * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Cataract * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Conjunctivitis * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Diplopia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Eye Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Photophobia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Vision Blurred * 1  3/224 (1.34%)  3 1/486 (0.21%)  1
Visual Impairment * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Vitreous Floaters * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Gastrointestinal disorders     
Abdominal Adhesions * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Abdominal Discomfort * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Abdominal Pain * 1  3/224 (1.34%)  3 3/486 (0.62%)  3
Abdominal Pain Lower * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Abdominal Pain Upper * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Breath Odour * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Change Of Bowel Habit * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Constipation * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Crohn's Disease * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Diarrhoea * 1  5/224 (2.23%)  5 2/486 (0.41%)  2
Dyspepsia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Dysphagia * 1  34/224 (15.18%)  37 34/486 (7.00%)  36
Epigastric Discomfort * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Eructation * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Faecal Incontinence * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gastritis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Gastroduodenitis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Gastrooesophageal Reflux Disease * 1  4/224 (1.79%)  4 7/486 (1.44%)  7
Haematochezia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Haemorrhoidal Haemorrhage * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haemorrhoids * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hiatus Hernia * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Intestinal Polyp * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Irritable Bowel Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Malocclusion * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Nausea * 1  8/224 (3.57%)  8 8/486 (1.65%)  8
Odynophagia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Oesophageal Oedema * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Paraesthesia Oral * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Periodontal Disease * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Polyp Colorectal * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Rectal Haemorrhage * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Tongue Discolouration * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Toothache * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Vomiting * 1  4/224 (1.79%)  4 5/486 (1.03%)  5
General disorders     
Adverse Drug Reaction * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Asthenia * 1  5/224 (2.23%)  6 0/486 (0.00%)  0
Axillary Pain * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Chest Discomfort * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Chest Pain * 1  2/224 (0.89%)  2 10/486 (2.06%)  10
Chills * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Crepitations * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Device Breakage * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Device Connection Issue * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Device Dislocation * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Drug Withdrawal Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Facial Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Fatigue * 1  6/224 (2.68%)  6 1/486 (0.21%)  1
Feeling Cold * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gait Disturbance * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Implant Site Paraesthesia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Infusion Site Extravasation * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Irritability * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Local Swelling * 1  7/224 (3.13%)  7 4/486 (0.82%)  4
Malaise * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Non-Cardiac Chest Pain * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Oedema Peripheral * 1  4/224 (1.79%)  5 2/486 (0.41%)  2
Pain * 1  3/224 (1.34%)  3 3/486 (0.62%)  3
Pyrexia * 1  2/224 (0.89%)  2 3/486 (0.62%)  3
Sensation Of Foreign Body * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Sensation Of Pressure * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Spinal Pain * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Swelling * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hepatobiliary disorders     
Hepatic Steatosis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Immune system disorders     
Drug Hypersensitivity * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hypersensitivity * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Latex Allergy * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Seasonal Allergy * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Infections and infestations     
Adenoviral Conjunctivitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Bacterial Infection * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Breast Abscess * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Bronchitis * 1  4/224 (1.79%)  4 1/486 (0.21%)  1
Cellulitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Diverticulitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Ear Infection * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Gastroenteritis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Gastroenteritis Viral * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Gastrointestinal Bacterial Infection * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Herpes Zoster * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Hordeolum * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Incision Site Infection * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Influenza * 1  1/224 (0.45%)  1 3/486 (0.62%)  4
Kidney Infection * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Laryngitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Nasopharyngitis * 1  3/224 (1.34%)  3 1/486 (0.21%)  1
Otitis Media * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pertussis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Pharyngitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pneumonia * 1  3/224 (1.34%)  3 1/486 (0.21%)  1
Pneumonia Primary Atypical * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Post Procedural Infection * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Reiter's Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Rhinitis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Sinusitis * 1  6/224 (2.68%)  6 5/486 (1.03%)  5
Staphylococcal Infection * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Stitch Abscess * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Tonsillitis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Tracheitis * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Tracheobronchitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Upper Respiratory Tract Infection * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Urinary Tract Infection * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Vulvovaginal Mycotic Infection * 1  1/224 (0.45%)  2 0/486 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol Poisoning * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Ankle Fracture * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Arthropod Bite * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Arthropod Sting * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Contusion * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Dural Tear * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Electric Shock * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Endotracheal Intubation Complication * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Epicondylitis * 1  1/224 (0.45%)  1 4/486 (0.82%)  4
Face Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Fall * 1  10/224 (4.46%)  10 27/486 (5.56%)  28
Foreign Body * 1  1/224 (0.45%)  2 0/486 (0.00%)  0
Graft Complication * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hand Fracture * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Head Injury * 1  0/224 (0.00%)  0 5/486 (1.03%)  6
Incision Site Complication * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Incision Site Erythema * 1  3/224 (1.34%)  3 0/486 (0.00%)  0
Incision Site Haematoma * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Incision Site Oedema * 1  8/224 (3.57%)  8 0/486 (0.00%)  0
Incision Site Pain * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Incorrect Dose Administered * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Injury * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Intervertebral Disc Injury * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Joint Dislocation * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Joint Injury * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Laceration * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Ligament Sprain * 1  1/224 (0.45%)  1 4/486 (0.82%)  4
Limb Crushing Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Limb Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Meniscus Lesion * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Muscle Strain * 1  5/224 (2.23%)  5 7/486 (1.44%)  7
Nail Avulsion * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Neck Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Periorbital Haematoma * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Post Laminectomy Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Post Procedural Constipation * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Post Procedural Haematoma * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Post-Traumatic Neck Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Procedural Dizziness * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Procedural Haemorrhage * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Procedural Headache * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Procedural Hypertension * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Procedural Nausea * 1  0/224 (0.00%)  0 5/486 (1.03%)  5
Procedural Vomiting * 1  0/224 (0.00%)  0 5/486 (1.03%)  5
Road Traffic Accident * 1  7/224 (3.13%)  7 15/486 (3.09%)  15
Spondylopathy Traumatic * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Sports Injury * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Toxicity To Various Agents * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Tracheal Deviation * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Wound Contamination * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Wound Dehiscence * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Wound Secretion * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Blood Triglycerides Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Investigations     
Blood Cholesterol Increased * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Blood Pressure Increased * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Blood Sodium Decreased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
C-Reactive Protein Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Colonoscopy * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Electrocardiogram T Wave Abnormal * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haematocrit Decreased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haemoglobin Decreased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Heart Rate Increased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Intraocular Pressure Test Abnormal * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Oxygen Saturation Decreased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Red Blood Cell Sedimentation Rate Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Reflex Test Abnormal * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Sleep Study Abnormal * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Transaminases Increased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Urine Output Decreased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Weight Decreased * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
White Blood Cell Count Increased * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Gout * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Metabolism and nutrition disorders     
Dehydration * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Diabetes Mellitus * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Hyperglycaemia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hyperlipidaemia * 1  0/224 (0.00%)  0 3/486 (0.62%)  3
Hypokalaemia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Type 2 Diabetes Mellitus * 1  2/224 (0.89%)  2 5/486 (1.03%)  5
Musculoskeletal and connective tissue disorders     
Ankylosing Spondylitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Arthralgia * 1  7/224 (3.13%)  7 14/486 (2.88%)  14
Arthritis * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Arthropathy * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Back Pain * 1  29/224 (12.95%)  34 44/486 (9.05%)  47
Bone Cyst * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Bone Deformity * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Bone Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Bunion * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Bursitis * 1  5/224 (2.23%)  5 3/486 (0.62%)  3
Cervical Spinal Stenosis * 1  2/224 (0.89%)  2 6/486 (1.23%)  6
Chondromalacia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Coccydynia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Exostosis * 1  7/224 (3.13%)  7 12/486 (2.47%)  13
Facet Joint Syndrome * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Fibromyalgia * 1  1/224 (0.45%)  1 4/486 (0.82%)  4
Flank Pain * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Intervertebral Disc Degeneration * 1  12/224 (5.36%)  15 20/486 (4.12%)  21
Intervertebral Disc Disorder * 1  4/224 (1.79%)  4 4/486 (0.82%)  4
Intervertebral Disc Protrusion * 1  18/224 (8.04%)  21 26/486 (5.35%)  27
Intervertebral Disc Space Narrowing * 1  3/224 (1.34%)  3 0/486 (0.00%)  0
Joint Crepitation * 1  5/224 (2.23%)  5 3/486 (0.62%)  4
Joint Hyperextension * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Joint Laxity * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Joint Lock * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Joint Range Of Motion Decreased * 1  0/224 (0.00%)  0 4/486 (0.82%)  4
Joint Stiffness * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Joint Swelling * 1  2/224 (0.89%)  2 3/486 (0.62%)  3
Kyphosis * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Limb Discomfort * 1  2/224 (0.89%)  2 2/486 (0.41%)  2
Lumbar Spinal Stenosis * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Meniscal Degeneration * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Muscle Atrophy * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Muscle Fatigue * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Muscle Spasms * 1  21/224 (9.38%)  24 40/486 (8.23%)  46
Muscle Tightness * 1  4/224 (1.79%)  5 11/486 (2.26%)  13
Muscle Twitching * 1  1/224 (0.45%)  1 2/486 (0.41%)  2
Muscular Weakness * 1  4/224 (1.79%)  4 10/486 (2.06%)  12
Musculoskeletal Chest Pain * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Musculoskeletal Discomfort * 1  11/224 (4.91%)  13 11/486 (2.26%)  12
Musculoskeletal Pain * 1  37/224 (16.52%)  42 67/486 (13.79%)  77
Musculoskeletal Stiffness * 1  9/224 (4.02%)  10 21/486 (4.32%)  24
Myalgia * 1  3/224 (1.34%)  3 24/486 (4.94%)  27
Myofascial Pain Syndrome * 1  0/224 (0.00%)  0 5/486 (1.03%)  5
Myofascial Spasm * 1  2/224 (0.89%)  2 1/486 (0.21%)  1
Neck Mass * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Neck Pain * 1  63/224 (28.13%)  68 106/486 (21.81%)  122
Osteoarthritis * 1  3/224 (1.34%)  3 5/486 (1.03%)  6
Osteochondritis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Osteopenia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Osteoporosis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pain In Extremity * 1  33/224 (14.73%)  37 64/486 (13.17%)  72
Pain In Jaw * 1  1/224 (0.45%)  1 3/486 (0.62%)  3
Patellofemoral Pain Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Periarthritis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Plantar Fasciitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Pseudarthrosis * 1  0/224 (0.00%)  0 29/486 (5.97%)  29
Rheumatoid Arthritis * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Rotator Cuff Syndrome * 1  7/224 (3.13%)  7 10/486 (2.06%)  10
Sacroiliitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Sensation Of Heaviness * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Soft Tissue Disorder * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Spinal Osteoarthritis * 1  10/224 (4.46%)  12 11/486 (2.26%)  16
Spondylitis * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Spondylolisthesis * 1  3/224 (1.34%)  3 2/486 (0.41%)  2
Synovial Cyst * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Temporomandibular Joint Syndrome * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Tendonitis * 1  1/224 (0.45%)  1 4/486 (0.82%)  4
Tenosynovitis * 1  4/224 (1.79%)  4 1/486 (0.21%)  1
Trigger Finger * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Vertebral Foraminal Stenosis * 1  9/224 (4.02%)  9 2/486 (0.41%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal Cell Carcinoma * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Colon Adenoma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Fibrous Cortical Defect * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Haemangioma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Lipoma * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Lung Neoplasm * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Melanocytic Naevus * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Nervous System Neoplasm * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Skin Papilloma * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Spinal Haemangioma * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Thyroid Neoplasm * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Nervous system disorders     
Allodynia * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Amnesia * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Arachnoid Cyst * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Balance Disorder * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Burning Sensation * 1  4/224 (1.79%)  4 7/486 (1.44%)  7
Carpal Tunnel Syndrome * 1  10/224 (4.46%)  10 16/486 (3.29%)  16
Cerebral Ischaemia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Cervical Myelopathy * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Cervicobrachial Syndrome * 1  0/224 (0.00%)  0 5/486 (1.03%)  5
Cervicogenic Headache * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Coordination Abnormal * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Cubital Tunnel Syndrome * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Dizziness * 1  7/224 (3.13%)  7 7/486 (1.44%)  8
Dizziness Postural * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Dysaesthesia * 1  4/224 (1.79%)  4 3/486 (0.62%)  3
Dyskinesia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Grand Mal Convulsion * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Headache * 1  25/224 (11.16%)  26 39/486 (8.02%)  41
Horner's Syndrome * 1  1/224 (0.45%)  1 0/486 (0.00%)  0
Hyperaesthesia * 1  1/224 (0.45%)  1 1/486 (0.21%)  1
Hyperpathia * 1  0/224 (0.00%)  0 1/486 (0.21%)  1
Hyperreflexia * 1  0/224 (0.00%)  0 2/486 (0.41%)  2
Hypersomnia * 1  2/224 (0.89%)  2 0/486 (0.00%)  0
Hypoaesthesia * 1  34/224 (15.18%)