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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

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: NCT00667459
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : September 22, 2014
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cervical Degenerative Disc Disease
Interventions Device: PRESTIGE® LP Cervical Disc
Device: ATLANTIS Anterior Cervical Plate
Enrollment 280
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Investigational Control
Hide Arm/Group Description PRESTIGE® LP Cervical Disc Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)
Period Title: Overall Study
Started 280 265
Completed 272 220
Not Completed 8 45
Reason Not Completed
Death             0             2
Lost to Follow-up             8             43
Arm/Group Title Investigational Control Total
Hide Arm/Group Description PRESTIGE® LP Cervical Disc Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876). Total of all reporting groups
Overall Number of Baseline Participants 280 265 545
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 280 participants 265 participants 545 participants
44.5  (8.8) 43.9  (8.8) 44.2  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Female
151
  53.9%
143
  54.0%
294
  53.9%
Male
129
  46.1%
122
  46.0%
251
  46.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Caucasian 271 243 514
Black 7 13 20
Asian 0 2 2
Hispanic 1 6 7
Other 1 1 2
Height  
Mean (Standard Deviation)
Unit of measure:  In.
Number Analyzed 280 participants 265 participants 545 participants
67.7  (4.1) 67.5  (4.2) 67.6  (4.2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Lbs.
Number Analyzed 280 participants 265 participants 545 participants
186.9  (45.0) 184.7  (41.5) 185.8  (43.3)
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Single 40 32 72
Married 189 204 393
Divorced 42 24 66
Separated 7 3 10
Widowed 2 2 4
Education Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
< High School 15 14 29
High School 57 77 134
> High School 206 173 379
Unknown 2 1 3
Worker's Compensation Case  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Yes 32 35 67
No 248 230 478
Unresolved Spinal Litigation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Yes 34 32 66
No 246 233 479
Tobacco Used  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Yes 74 92 166
No 206 173 379
Alcohol Used  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Yes 150 141 291
No 130 124 254
Preop Work Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 280 participants 265 participants 545 participants
Yes 188 166 354
No 92 99 191
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. Postoperative Neck Disability Index score improvement of at least a 15-points from preoperative;
  2. Maintenance or improvement in neurological status;
  3. Disc height success which was defined as either the anterior or posterior measurements meeting the criteria of “Postoperative Height - 6 Week Postoperative Height ≥ -2mm”;
  4. No serious adverse event classified as implant associated or implant/surgical procedure associated; and
  5. No secondary surgical procedure classified as a "failure."
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis dataset for this study consists of all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 226 investigational subjects and 171 control subjects.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 226 171
Measure Type: Number
Unit of Measure: percentage of participants
70.4 63.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 – p0 > -d | data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 0.995
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.032
Confidence Interval (2-Sided) 95%
-0.070 to 0.134
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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. If the posterior probability is at least 0.95, a claim of superiority can be made.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.736
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
2.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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 219
Measure Type: Number
Unit of Measure: percentage of participants
87.8 80.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 – p0 > -d | data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 1.0
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.048
Confidence Interval (2-Sided) 95%
-0.020 to 0.118
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.912
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
3.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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 220
Measure Type: Number
Unit of Measure: percentage of participants
93.3 83.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 1.0
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.099
Confidence Interval (2-Sided) 95%
0.038 to 0.161
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.999
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
4.Secondary Outcome
Title Rate of Disc Height Success
Hide Description Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 224 subjects in the investigational group and 164 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 224 164
Measure Type: Number
Unit of Measure: percentage of participants
91.5 95.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 0.992
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.034
Confidence Interval (2-Sided) 95%
-0.085 to 0.021
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.097
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
5.Secondary Outcome
Title Neck Pain Success Rate
Hide Description Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 219
Measure Type: Number
Unit of Measure: percentage of participants
96.3 97.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 1.0
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.010
Confidence Interval (2-Sided) 95%
-0.043 to 0.023
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.273
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
6.Secondary Outcome
Title Arm Pain Success Rate
Hide Description Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 100 max) was derived by multiplying the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 268 219
Measure Type: Number
Unit of Measure: percentage of participants
96.3 95.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 1.0
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.019
Confidence Interval (2-Sided) 95%
-0.018 to 0.058
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.845
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
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 of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 264 216
Measure Type: Number
Unit of Measure: percentage of participants
83.7 86.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 0.936
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.047
Confidence Interval (2-Sided) 95%
-0.113 to 0.021
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
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 of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 264 216
Measure Type: Number
Unit of Measure: percentage of participants
77.7 69.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin is 0.1.
Statistical Test of Hypothesis P-Value 1.0
Comments The posterior probably of non-inferiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.105
Confidence Interval (2-Sided) 95%
0.020 to 0.190
Estimation Comments The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, 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 0.992
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.
9.Secondary Outcome
Title Gait Success Rate
Hide Description Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 270 subjects in the investigational group and 220 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 220
Measure Type: Number
Unit of Measure: percentage of participants
99.3 99.5
10.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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for operative time, which leads to 280 subjects in the investigational group and 265 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 280 265
Mean (Standard Deviation)
Unit of Measure: hrs
1.5  (0.6) 1.4  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments Superiority comparison of the operative time in two treatment groups was assessed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments [Not Specified]
11.Secondary Outcome
Title Blood Loss
Hide Description [Not Specified]
Time Frame During the time of operation, approximately 1.5 hours.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for blood loss, which leads to 278 subjects in the investigational group and 263 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 278 263
Mean (Standard Deviation)
Unit of Measure: ml
50.5  (73.5) 57.5  (68.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments Superiority comparison of the blood loss in two treatment groups was assessed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments [Not Specified]
12.Secondary Outcome
Title Hospital Stay
Hide Description [Not Specified]
Time Frame During the time of hospital stay, average of 1 day.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable information for hospital stay, which leads to 280 subjects in the investigational group and 265 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 280 265
Mean (Standard Deviation)
Unit of Measure: days
1.0  (0.5) 1.0  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments Superiority comparison of the hospital stay in two treatment groups was assessed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments The posterior probably of superiority was calculated and presented instead of the p-value.
Method Bayesian logistic model
Comments [Not Specified]
13.Secondary Outcome
Title Rate of Secondary Surgery at Index Level
Hide Description Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of patients who had secondary surgeries at index level.
Time Frame 24 months post-operation
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Hide Analysis Population Description
For this endpoint, the analysis consists of all subjects in the primary analysis dataset with 280 subjects in the investigational control and 265 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 280 265
Measure Type: Number
Unit of Measure: percentage of participants
5.0 7.9
14.Secondary Outcome
Title Change of Neck Disability Index Score From Baseline
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). Change of NDI was defined as NDI at 24 month minus NDI at baseline.
Time Frame Baseline and 24 months post-operation
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Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
NDI at baseline (n=280, 264) 55.5  (14.7) 56.4  (15.9)
NDI at 24 months (n=270, 220) 15.6  (18.3) 22.4  (21.5)
NDI change (n=270, 219) -39.7  (21.0) -33.9  (21.8)
15.Secondary Outcome
Title Change of Neck Pain Score From Baseline
Hide Description Numerical rating scales were used to evaluate neck pain intensity and frequency. Patients rated 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 recorded 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 (0 to100) was the product of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.
Time Frame Baseline and 24 months post-operation
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Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain score at both baseline and 24 months, which leads to 270 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 270 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
Neck Pain at baseline (n=280, 264) 67.0  (20.8) 69.3  (21.5)
Neck Pain at 24 months (n=270, 220) 10.6  (19.2) 16.6  (24.4)
Neck Pain Change (n=270, 219) -56.6  (28.2) -52.1  (28.3)
16.Secondary Outcome
Title Change of Arm Pain Score From Baseline
Hide Description Numerical rating scales were also used to evaluate arm pain intensity and frequency. Patients rated 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 recorded 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 (0 to 100) was the product of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.
Time Frame Baseline and 24 months post-operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain score at both baseline and 24 months, which leads to 268 subjects in the investigational group and 219 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 268 219
Mean (Standard Deviation)
Unit of Measure: units on a scale
Arm pain score at baseline (n=280, 264) 59.6  (26.3) 62.4  (28.5)
Arm pain score at 24 months (n=268, 220) 8.5  (18.3) 14.2  (24.3)
Arm pain score change (n=268, 219) -52.0  (31.4) -48.0  (32.7)
17.Secondary Outcome
Title Change of General Health Status -- SF-36 PCS From Baseline
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 were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.
Time Frame Baseline and 24 months post-operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable PCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 264 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 PCS at baseline (n=279, 263) 32.2  (7.4) 32.0  (7.5)
SF-36 PCS at 24 months (n=265, 218) 46.6  (11.4) 44.4  (12.0)
SF-36 PCS change (n=264, 216) 14.3  (11.6) 11.9  (10.9)
18.Secondary Outcome
Title Change of General Health Status -- SF-36 MCS From Baseline
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 were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.
Time Frame Baseline and 24 months post-operation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable MCS score at both baseline and 24 months, which leads to 264 subjects in the investigational group and 216 subjects in the control group.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
PRESTIGE® LP Cervical Disc
Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Overall Number of Participants Analyzed 264 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
SF-36 MCS at baseline (n=279, 263) 44.5  (11.5) 42.7  (12.4)
SF-36 MCS at 24 months (n=265, 218) 52.6  (9.6) 50.2  (11.1)
SF-36 MCS change (n=264, 216) 8.1  (12.3) 7.2  (13.9)
Time Frame up to 24 months
Adverse Event Reporting Description The adverse events, originally collected in FDA proposed categories, were grouped into organ systems.
 
Arm/Group Title Investigational Control
Hide Arm/Group Description PRESTIGE® LP Cervical Disc Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
All-Cause Mortality
Investigational Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Investigational Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   133/280 (47.50%)      98/265 (36.98%)    
Blood and lymphatic system disorders     
Other *  1/280 (0.36%)  2 0/265 (0.00%)  0
Cardiac disorders     
Cardiac Disorders *  9/280 (3.21%)  10 7/265 (2.64%)  8
Congenital, familial and genetic disorders     
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
Ear and labyrinth disorders     
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
Other Pain *  1/280 (0.36%)  1 0/265 (0.00%)  0
Eye disorders     
Other *  3/280 (1.07%)  5 1/265 (0.38%)  1
Other Pain *  1/280 (0.36%)  1 0/265 (0.00%)  0
Gastrointestinal disorders     
Dysphagia/Dysphonia *  2/280 (0.71%)  3 1/265 (0.38%)  1
Gastrointestinal *  13/280 (4.64%)  22 12/265 (4.53%)  20
General disorders     
Implant Events *  4/280 (1.43%)  4 0/265 (0.00%)  0
Other *  1/280 (0.36%)  1 2/265 (0.75%)  2
Other Pain *  3/280 (1.07%)  3 3/265 (1.13%)  4
Immune system disorders     
Other *  1/280 (0.36%)  1 3/265 (1.13%)  3
Infections and infestations     
Infection *  11/280 (3.93%)  17 8/265 (3.02%)  8
Injury, poisoning and procedural complications     
Trauma *  20/280 (7.14%)  22 10/265 (3.77%)  10
Wound (Non-Infectious) *  5/280 (1.79%)  5 4/265 (1.51%)  4
Spinal Events *  2/280 (0.71%)  2 2/265 (0.75%)  2
Other *  9/280 (3.21%)  9 3/265 (1.13%)  3
Other Pain *  10/280 (3.57%)  11 6/265 (2.26%)  7
Investigations     
Other *  3/280 (1.07%)  5 1/265 (0.38%)  2
Metabolism and nutrition disorders     
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Heterotopic Ossification *  11/280 (3.93%)  13 8/265 (3.02%)  12
Neck and/or Arm Pain *  37/280 (13.21%)  52 24/265 (9.06%)  36
Non-Union *  0/280 (0.00%)  0 6/265 (2.26%)  6
Spinal Events *  40/280 (14.29%)  77 31/265 (11.70%)  54
Other *  0/280 (0.00%)  0 5/265 (1.89%)  6
Other Pain *  27/280 (9.64%)  38 16/265 (6.04%)  21
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  2/280 (0.71%)  4 2/265 (0.75%)  2
Other *  3/280 (1.07%)  3 1/265 (0.38%)  1
Nervous system disorders     
Neurological *  35/280 (12.50%)  52 27/265 (10.19%)  32
Spinal Events *  1/280 (0.36%)  1 2/265 (0.75%)  3
Other *  3/280 (1.07%)  3 2/265 (0.75%)  3
Other Pain *  10/280 (3.57%)  12 2/265 (0.75%)  2
Pregnancy, puerperium and perinatal conditions     
Other *  0/280 (0.00%)  0 1/265 (0.38%)  1
Psychiatric disorders     
Other *  6/280 (2.14%)  8 5/265 (1.89%)  6
Renal and urinary disorders     
Urogenital *  15/280 (5.36%)  20 4/265 (1.51%)  4
Respiratory, thoracic and mediastinal disorders     
Respiratory *  7/280 (2.50%)  9 1/265 (0.38%)  1
Dysphagia/Dysphonia *  1/280 (0.36%)  1 0/265 (0.00%)  0
Other Pain *  1/280 (0.36%)  1 0/265 (0.00%)  0
Surgical and medical procedures     
Other *  3/280 (1.07%)  4 2/265 (0.75%)  2
Vascular disorders     
Vascular *  6/280 (2.14%)  7 0/265 (0.00%)  0
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Investigational Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   242/280 (86.43%)      211/265 (79.62%)    
Blood and lymphatic system disorders     
Other *  1/280 (0.36%)  1 4/265 (1.51%)  4
Other Pain *  0/280 (0.00%)  0 2/265 (0.75%)  2
Cardiac disorders     
Cardiac Disorders *  8/280 (2.86%)  11 11/265 (4.15%)  12
Congenital, familial and genetic disorders     
Other *  0/280 (0.00%)  0 1/265 (0.38%)  1
Ear and labyrinth disorders     
Other *  5/280 (1.79%)  6 1/265 (0.38%)  2
Other Pain *  1/280 (0.36%)  1 0/265 (0.00%)  0
Endocrine disorders     
Other *  2/280 (0.71%)  3 2/265 (0.75%)  2
Eye disorders     
Other *  3/280 (1.07%)  3 2/265 (0.75%)  2
Other Pain *  1/280 (0.36%)  1 1/265 (0.38%)  1
Gastrointestinal disorders     
Dysphagia/Dysphonia *  19/280 (6.79%)  21 21/265 (7.92%)  22
Gastrointestinal *  25/280 (8.93%)  33 30/265 (11.32%)  48
Other *  0/280 (0.00%)  0 1/265 (0.38%)  1
Other Pain *  1/280 (0.36%)  1 1/265 (0.38%)  1
General disorders     
Implant Events *  12/280 (4.29%)  13 5/265 (1.89%)  5
Other *  11/280 (3.93%)  12 11/265 (4.15%)  14
Other Pain *  6/280 (2.14%)  6 13/265 (4.91%)  13
Immune system disorders     
Other *  6/280 (2.14%)  7 1/265 (0.38%)  1
Infections and infestations     
Infection *  28/280 (10.00%)  40 22/265 (8.30%)  29
Other *  0/280 (0.00%)  0 1/265 (0.38%)  1
Injury, poisoning and procedural complications     
Anatomical/technical difficulty *  2/280 (0.71%)  2 0/265 (0.00%)  0
Other *  13/280 (4.64%)  14 4/265 (1.51%)  4
Other Pain *  17/280 (6.07%)  23 16/265 (6.04%)  20
Trauma *  44/280 (15.71%)  49 30/265 (11.32%)  34
Wound(Non-Infectious) *  20/280 (7.14%)  29 9/265 (3.40%)  9
Investigations     
Other *  15/280 (5.36%)  16 6/265 (2.26%)  7
Metabolism and nutrition disorders     
Other *  4/280 (1.43%)  4 3/265 (1.13%)  3
Other Pain *  2/280 (0.71%)  2 1/265 (0.38%)  1
Musculoskeletal and connective tissue disorders     
Heterotopic Ossification *  16/280 (5.71%)  18 7/265 (2.64%)  9
Neck and/or Arm Pain *  125/280 (44.64%)  223 113/265 (42.64%)  177
Non-Union *  0/280 (0.00%)  0 24/265 (9.06%)  24
Other *  17/280 (6.07%)  19 8/265 (3.02%)  9
Other Pain *  88/280 (31.43%)  121 80/265 (30.19%)  122
Spinal Events *  50/280 (17.86%)  91 27/265 (10.19%)  42
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer *  1/280 (0.36%)  1 0/265 (0.00%)  0
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
Spinal Events *  0/280 (0.00%)  0 1/265 (0.38%)  1
Nervous system disorders     
Dysphagia/Dysphonia *  1/280 (0.36%)  1 0/265 (0.00%)  0
Neurological *  116/280 (41.43%)  190 92/265 (34.72%)  185
Other *  5/280 (1.79%)  6 12/265 (4.53%)  14
Other Pain *  43/280 (15.36%)  50 32/265 (12.08%)  35
Spinal Events *  1/280 (0.36%)  1 1/265 (0.38%)  1
Psychiatric disorders     
Other *  17/280 (6.07%)  21 16/265 (6.04%)  23
Renal and urinary disorders     
Other *  0/280 (0.00%)  0 1/265 (0.38%)  1
Urogenital *  16/280 (5.71%)  22 6/265 (2.26%)  7
Reproductive system and breast disorders     
Other *  2/280 (0.71%)  2 1/265 (0.38%)  1
Respiratory, thoracic and mediastinal disorders     
Dysphagia/Dysphonia *  7/280 (2.50%)  7 0/265 (0.00%)  0
Other Pain *  5/280 (1.79%)  5 2/265 (0.75%)  2
Respiratory *  20/280 (7.14%)  25 16/265 (6.04%)  22
Skin and subcutaneous tissue disorders     
Other *  12/280 (4.29%)  13 10/265 (3.77%)  11
Other Pain *  1/280 (0.36%)  1 0/265 (0.00%)  0
Social circumstances     
Other *  2/280 (0.71%)  2 0/265 (0.00%)  0
Surgical and medical procedures     
Other *  1/280 (0.36%)  1 2/265 (0.75%)  2
Vascular disorders     
Other *  1/280 (0.36%)  1 0/265 (0.00%)  0
Vascular *  6/280 (2.14%)  6 4/265 (1.51%)  4
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Clinical Department
Organization: Medtronic Spinal
Phone: 1800-876-3133 ext 6068
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00667459     History of Changes
Other Study ID Numbers: PRESTIGE® LP Protocol, #P03-03
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: August 22, 2014
Results First Posted: September 22, 2014
Last Update Posted: February 5, 2015