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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090029 S003/ PAS001 |
| Study Name |
10 Year Extended f/u of IDE Subjects
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| Device Name |
PRESTIGE LP(TM) CERVICAL DISC
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
Sponsor Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Detailed Study Protocol Parameters |
| Study Objectives |
10 Year Extended Follow-up of IDE Subjects Treated with the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels is a 10-year post-approval study (PAS) to evaluate the longer term safety and effectiveness of the PRESTIGE LP™ Cervical Disc.
This study has a multi-center, prospective, randomized, controlled design. The bi-level ACD-LP treatment will be compared to the control treatment, a bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS® Cervical Plate System.
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| Study Population |
Patients who have been diagnosed with symptomatic cervical degenerative disc disease at two adjacent levels (from C3-C7) according to the specified inclusion/exclusion criteria as stated in the protocol (Version G).
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| Sample Size |
397 subjects treated in the pivotal investigational device exemption (IDE) study (209 2-level PRESTIGE LP™ subjects and 188 2-level ACDF control subjects)
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| Key Study Endpoints |
The primary endpoint was (individual subject) overall success at 24 months, a composite variable which included safety and effectiveness considerations, and was defined as follows:
1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;
2. Maintenance or improvement in neurological status;
3. No serious adverse event classified as implant associated or implant/surgical procedure associated (as determined by an independent clinical adjudication committee); and
4. No additional surgical procedure classified as a “failure.
Secondary endpoints, measured in both treatment groups, included neck pain, arm pain, quality of life (SF-36 Physical Component Score [PCS] and Mental Component Score [MCS]), gait assessment (Nurick’s classification), subject satisfaction, subject perceived effect, physician perception of results, radiographic success (defined differently in the two treatment groups), range of motion, Functional Spinal Unit (FSU) height, implant condition, heterotopic ossification, and return to work.
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| Follow-up Visits and Length of Follow-up |
120 months (+/-3 months)
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
181 subjects in the Investigational (INV) cohort (down from 209 enrolled in the IDE trial due to clinical sites not participating at 120 months); 160 subjects in the Control (CTR) cohort (down from 188 enrolled in the IDE trial)
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| Actual Number of Sites Enrolled |
19 investigational sites
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| Patient Follow-up Rate |
INV follow-up rate was reported as 86.0% at 120 months; CTR follow-up rate was reported as 84.9% at 120 months
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| Final Safety Findings |
There was no difference in the risk of subjects experiencing an adverse event between the INV group and the CTR group. There were fewer subjects experiencing a secondary surgical intervention in the INV group compared to the CTR group
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| Final Effect Findings |
Bayesian analyses shows a posterior probability of non-inferiority of essentially 100% and a posterior probability of superiority of 99.9% for overall success of the INV group compared to the CTR group.
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| Study Strengths & Weaknesses |
This Extended Follow-up study successfully demonstrated superiority of the 2-level Prestige LP disc compared to the 2-level ACDF control group. While the closure of several clinical sites introduce a potential source of bias related to possible clinical differences between patients in the 120 month PAS group and patients not participating, an analysis of the baseline demographic data and last observed effectiveness outcomes for missing subjects compared to subjects observed at 120 months indicate that there is no statistically significant difference between groups. Additional results of a tipping point sensitivity analysis show that the non-inferiority and to a lesser degree the superiority conclusions, are robust to the missing data.
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| Recommendations for Labeling Changes |
Labeling changes were recommended to reflect the 120 month outcomes.
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