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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150017 / PAS001 |
| Study Name |
MOTION Extend Study
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| Device Name |
CARTIVA SYNTHETIC CARTILAGE IMPLANT
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| Clinical Trial Number(s) |
NCT00969969
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Evaluate and confirm long-term the established safety and effectiveness of the Cartiva SCI implant.
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| Study Population |
Subjects treated with Cartiva SCI in the PMA study.
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| Sample Size |
All sites which enrolled subjects in the MOTION study will be invited to participate in the PAS, and all subjects at the participating sites and who meet the above inclusion/exclusion criteria will be invited to enroll in the PAS. This includes 135 Cartiva subjects (119 randomized and 16 roll-in) eligible for study participation. Assuming a 15% lost to follow-up rate, it’s estimated that 115 subjects will have 5-year device status determined.
A one group ¿2 test with a 0.05 one-sided significance level will have 80% power to detect the difference between the Null hypothesis proportion, ¿0 + ¿, of 0.235 and the Alternative proportion, ¿A, of 0.142 when the sample size is 115.
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| Key Study Endpoints |
The primary endpoint will evaluate the long-term safety of the Cartiva implant by demonstrating the following:
1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.
2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the MOTION study or novel.
Secondary
1) Evaluation of maintenance of range of motion
2) Wear characteristics or device degradation for any Cartiva implant removed
3) Pain and function over time (VAS, FAAM ADL and Sports)
4) Evaluation of radiographic findings (radiolucency, bony reactions, and heterotopic ossification) looking at presence or progression from 24 months to 5+ years as well as correlation with the 5+ years clinical outcomes (effectiveness and safety).
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| Follow-up Visits and Length of Follow-up |
Each patient will be asked to return for clinical and radiographic evaluations at 5 years post-operative. If a subject, is already past their 5-year visit window, the subject’s 5+ year visit will be used for the 5-year time point. The follow-up window is 4 years and 8 months, or later from surgery. If a subject is unwilling to return to clinic but can provide the status of their implant that information will be included and used for the analysis of the primary endpoint which is survivorship of the implant. The subject will also be asked to complete the subject assessments (VAS and FAAM).
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
112
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| Actual Number of Sites Enrolled |
12
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| Patient Follow-up Rate |
At 60+ months, the follow-up rate for device survivorship was 88.8%, the follow-up rate for clinical assessment was 84.8%, and the follow-up rate for radiographic assessment was 77.6%.
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| Final Safety Findings |
Primary Endpoint:
Cumulative device removal rate from 2-5 years: 7.6% (9/119, 90% CI (0.0%, 11.28%)). This rate was non-inferior (margin 0.10) to the expected removal rate (13.5%) in the 2-5 year period estimated based on the 24 month data. No unanticipated safety concerns arose after Month 24 up to 5 years.
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| Final Effect Findings |
Secondary Endpoint:
Evaluation of maintenance of range of motion: At 5 years, mean active MTP dorsiflexion scores maintained an improvement compared to baseline and compared to the arthrodesis comparator group.
Secondary Endpoint:
Pain and function over time (VAS, FAAM ADL and Sports): Maintenance of improvement from baseline between 2-5 years.
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| Study Strengths & Weaknesses |
This study met its performance goal and had adequate follow-up rates and sample size.
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| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results. The updated label will reflect the long-term (5 years) postmarket performance of the device.
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