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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

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: NCT00310440
Recruitment Status : Completed
First Posted : April 4, 2006
Results First Posted : February 10, 2016
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
CeraPedics, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Intervertebral Disk Degeneration
Interventions Device: P-15 Synthetic osteoconductive bone substitute
Other: Autologous bone
Enrollment 319
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Period Title: Overall Study
Started 165 154
Completed 139 141
Not Completed 26 13
Reason Not Completed
Lost to Follow-up             17             8
Withdrawal by Subject             2             1
Missed 12 Month Visit             7             4
Arm/Group Title Bone Graft Substitute Autologous Bone Total
Hide Arm/Group Description

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

 Total of all reporting groups
Overall Number of Baseline Participants 165 154 319
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 154 participants 319 participants
47.7  (9.7) 45.7  (9.4) 46.8  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 154 participants 319 participants
Female
95
  57.6%
97
  63.0%
192
  60.2%
Male
70
  42.4%
57
  37.0%
127
  39.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 154 participants 319 participants
Hispanic or Latino
7
   4.2%
4
   2.6%
11
   3.4%
Not Hispanic or Latino
157
  95.2%
150
  97.4%
307
  96.2%
Unknown or Not Reported
1
   0.6%
0
   0.0%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 154 participants 319 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.3%
Asian
4
   2.4%
1
   0.6%
5
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   3.0%
6
   3.9%
11
   3.4%
White
151
  91.5%
144
  93.5%
295
  92.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   2.4%
3
   1.9%
7
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 165 participants 154 participants 319 participants
Canada 29 26 55
United States 136 128 264
1.Primary Outcome
Title Radiologic Fusion
Hide Description Successful fusion was based on roentgenographic examination showing: evidence of bridging trabecular bone between the involved motion segments, translational motion <3mm, and angular motion <5 degrees. If there was a lack of evidence of fusion on 12 month plain x-ray examination, a CT-scan was performed and final determination of the fusion status was made using the CT reading. The criteria for fusion on CT scans were: trabecular bone formation patterns within the intervertebral disc space and bridging bone formation that crosses the interspace.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that have radiological data at 12 months including imputed data.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 145 141
Measure Type: Number
Unit of Measure: participants
Fused 129 121
No Evidence of Fusion 16 20
2.Primary Outcome
Title Change in of the Overall Neck Disability Index (NDI) Score From Baseline.
Hide Description The NDI consists of ten items addressing functional activities (personal care, lifting, reading, work, driving, sleeping, recreational activities), pain intensity, concentration and headache. For each item, there are six potential responses, describing increasing degrees of disability (no disability = 0 to total disability = 5). An overall NDI score, out of 100, is calculated by adding up the scores for each item and multiplying by two. A higher NDI score indicates greater disability.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 161 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
28.75
(25.81 to 31.69)
27.40
(24.35 to 30.45)
3.Primary Outcome
Title Neurologic Success
Hide Description The neurological endpoint is a binary variable. Neurologic success was assessed in the motor, sensory and reflex domains specific for the cervical spine as follows: maintenance or improvement of motor function in the elbow flexors (i.e. biceps muscle), elbow extensors (i.e. triceps muscle) and wrist extensors of both arms; maintenance or improvement of sensory function of both arms; maintenance or improvement of reflexes of both arms as measured at biceps tendon, triceps tendon and brachioradialis (supinator) reflex AND absence of Babinski reflex (if not present prior to surgery). Worsening of neurological status (neurological failure) was defined as a permanent decline in the subject's neurological status based on adjudication of accumulated neurological data by an independent blinded evaluator.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The total number of observed subjects.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 143 143
Measure Type: Number
Unit of Measure: participants
Yes 134 133
No 9 10
4.Primary Outcome
Title Complications
Hide Description Any AE within 12 months of surgery.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 165 154
Measure Type: Number
Unit of Measure: participants
Yes 138 127
No 27 27
5.Secondary Outcome
Title Mean Change in Pain at Neck Visual Analog Scale (VAS).
Hide Description The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from "No pain at all" (0) to "Worst imaginable pain" (10). The change in pain is calculated by subtracting the 12 month score from the baseline score.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 161 152
Mean (95% Confidence Interval)
Unit of Measure: cm
4.45
(4.00 to 4.90)
4.39
(3.96 to 4.82)
6.Secondary Outcome
Title Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).
Hide Description The pain VAS is a continuous scale upon which the subject indicates their pain level ranging from "No pain at all" (0) to "Worst imaginable pain" (10). The change in pain is calculated by subtracting the 12 month score from the baseline score.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 161 152
Mean (95% Confidence Interval)
Unit of Measure: cm
4.89
(4.44 to 5.34)
4.85
(4.40 to 5.30)
7.Secondary Outcome
Title Success Rates Measured by Aggregated Modified Odom's Criteria
Hide Description Subjects selected one of four categories: Excellent (Improvement Greater than or Equal to 80%, Deterioration Less than 10%), Good (Improvement Greater than or Equal to 70%, Deterioration Less than 15%), Fair (Improvement Greater than or Equal to 50%, Deterioration Less than 20%) or Poor (Improvement Less than 50%, Deterioration Greater than 20%).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects that had data available at the 12 month visit were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 129 129
Measure Type: Number
Unit of Measure: participants
Excellent: Improvement GE 80% Deterioration LT 10% 80 80
Good: Improvement GE 70% Deterioration LT 15% 25 25
Fair: Improvement GE 50% Deterioration LT 20% 16 15
Poor: Improvement LT 50% Deterioration GT 20% 8 9
8.Secondary Outcome
Title Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).
Hide Description The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the PCS: physical functioning, role-physical, bodily pain, general health. The PCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 161 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
10.02
(8.39 to 11.66)
9.95
(8.25 to 11.65)
9.Secondary Outcome
Title Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).
Hide Description The SF-36 v2 (Medical Outcomes Trust, Boston, MA) is a multipurpose, patient-reported short-form health survey with 36 questions available in several languages. It yields two composite scores: one for physical health (Physical Composite Score - PCS) and one for mental health (Mental Composite Score - MCS) that are comprised of eight domains. The following domains make up the MCS: vitality, social functioning, role-emotional, mental health. The MCS ranges from a score of 0 (lowest possible level of functioning) to a score of 100 (highest possible level of functioning).
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 161 152
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
8.33
(6.66 to 10.01)
8.21
(6.48 to 9.95)
10.Secondary Outcome
Title Kyphosis
Hide Description Kyphosis is evaluated in degrees.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) subjects who had images available at 12 months were included in this analysis. Six subjects that had major protocol deviations with the potential to impact the primary endpoint results were not included in the PP population.
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description:

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Overall Number of Participants Analyzed 113 116
Mean (Standard Deviation)
Unit of Measure: degrees
3.0  (5.0) 3.8  (4.9)
Time Frame Adverse events were collected at all visits between baseline and 24 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bone Graft Substitute Autologous Bone
Hide Arm/Group Description

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
All-Cause Mortality
Bone Graft Substitute Autologous Bone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Bone Graft Substitute Autologous Bone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/165 (27.27%)      35/154 (22.73%)    
Cardiac disorders     
Pericarditis † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Gastrointestinal disorders     
Oesophageal rupture † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Retroperitoneal fibrosis † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
General disorders     
Hernia † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Implant site effusion † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Infections and infestations     
Infection † 1  2/165 (1.21%)  2 0/154 (0.00%)  0
Bronchitis † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Diverticulitis † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Meningitis viral † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Tooth abscess † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Urinary tract infection † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Injury, poisoning and procedural complications     
Humerus fracture † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Overdose † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Radial nerve injury † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Investigations     
Blood urine present † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pseudarthrosis † 1  4/165 (2.42%)  4 4/154 (2.60%)  4
Back pain † 1  3/165 (1.82%)  3 3/154 (1.95%)  3
Intervertebral disc protrusion † 1  2/165 (1.21%)  2 3/154 (1.95%)  3
Rotator cuff syndrome † 1  3/165 (1.82%)  3 1/154 (0.65%)  1
Lumbar spinal stenosis † 1  1/165 (0.61%)  1 2/154 (1.30%)  2
Musculoskeletal pain † 1  3/165 (1.82%)  3 0/154 (0.00%)  0
Pain in extremity † 1  3/165 (1.82%)  3 0/154 (0.00%)  0
Cervical spinal stenosis † 1  1/165 (0.61%)  1 1/154 (0.65%)  1
Intervertebral disc degeneration † 1  1/165 (0.61%)  1 1/154 (0.65%)  1
Neck pain † 1  2/165 (1.21%)  2 0/154 (0.00%)  0
Osteoarthritis † 1  2/165 (1.21%)  2 0/154 (0.00%)  0
Arthralgia † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Plantar fasciitis † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Rheumatoid arthritis † 1  1/165 (0.61%)  2 0/154 (0.00%)  0
Spinal osteoarthritis † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Tenosynovitis stenosans † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Trigger finger † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphocytic leukaemia † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Chronic lymphocytic leukaemia stage 0 † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Renal cancer † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
T-cell lymphoma † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Nervous system disorders     
Radiculopathy † 1  9/165 (5.45%)  10 8/154 (5.19%)  9
Carpal tunnel syndrome † 1  0/165 (0.00%)  0 3/154 (1.95%)  4
Complex regional pain syndrome † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Convulsion † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Lumbar radiculopathy † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Myelopathy † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Radiculitis † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Radiculitis cervical † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Thoracic outlet syndrome † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Transient ischaemic attack † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Renal and urinary disorders     
Nephrolithiasis † 1  0/165 (0.00%)  0 1/154 (0.65%)  2
Reproductive system and breast disorders     
Breast mass † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal polyps † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Pharyngeal haematoma † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Pulmonary mass † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Sleep apnoea syndrome † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Skin and subcutaneous tissue disorders     
Dermal cyst † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Ingrowing nail † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Surgical and medical procedures     
Surgery † 1  1/165 (0.61%)  1 3/154 (1.95%)  3
Shoulder operation † 1  1/165 (0.61%)  1 2/154 (1.30%)  2
Limb operation † 1  1/165 (0.61%)  1 1/154 (0.65%)  1
Thyroidectomy † 1  2/165 (1.21%)  2 0/154 (0.00%)  0
Arthroscopic surgery † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Elbow operation † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Gastrointestinal surgery † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Hernia repair † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Hip arthroplasty † 1  1/165 (0.61%)  2 0/154 (0.00%)  0
Hysterectomy † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Knee arthroplasty † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Nasal septal operation † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Rotator cuff repair † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
Shoulder arthroplasty † 1  0/165 (0.00%)  0 1/154 (0.65%)  1
Uterine operation † 1  1/165 (0.61%)  1 0/154 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bone Graft Substitute Autologous Bone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   136/165 (82.42%)      128/154 (83.12%)    
Gastrointestinal disorders     
Dysphagia † 1  31/165 (18.79%)  32 30/154 (19.48%)  31
Musculoskeletal and connective tissue disorders     
Neck pain † 1  67/165 (40.61%)  90 73/154 (47.40%)  100
Pain in extremity † 1  31/165 (18.79%)  36 23/154 (14.94%)  30
Back pain † 1  27/165 (16.36%)  27 25/154 (16.23%)  28
Musculoskeletal pain † 1  23/165 (13.94%)  26 21/154 (13.64%)  23
Muscle spasms † 1  15/165 (9.09%)  15 22/154 (14.29%)  25
Pseudarthrosis † 1  17/165 (10.30%)  20 18/154 (11.69%)  23
Arthralgia † 1  11/165 (6.67%)  11 10/154 (6.49%)  10
Musculoskeletal stiffness † 1  13/165 (7.88%)  15 8/154 (5.19%)  9
Myalgia † 1  9/165 (5.45%)  10 8/154 (5.19%)  8
Intervertebral disc protrusion † 1  5/165 (3.03%)  5 11/154 (7.14%)  12
Musculoskeletal discomfort † 1  6/165 (3.64%)  9 10/154 (6.49%)  12
Nervous system disorders     
Radiculopathy † 1  48/165 (29.09%)  75 55/154 (35.71%)  74
Headache † 1  17/165 (10.30%)  18 23/154 (14.94%)  29
Hypoaesthesia † 1  14/165 (8.48%)  16 20/154 (12.99%)  27
Carpal tunnel syndrome † 1  12/165 (7.27%)  12 9/154 (5.84%)  11
Paraesthesia † 1  7/165 (4.24%)  8 12/154 (7.79%)  14
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lead Clinical Research Associate
Organization: Nor Consult, LLC
Phone: 2066076861
EMail: p15@nor-consult.com
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Responsible Party: CeraPedics, Inc
ClinicalTrials.gov Identifier: NCT00310440    
Other Study ID Numbers: 1003
First Submitted: April 3, 2006
First Posted: April 4, 2006
Results First Submitted: December 10, 2015
Results First Posted: February 10, 2016
Last Update Posted: March 12, 2020