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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
H200001 / PAS001 |
| Date Original Protocol Accepted |
02/17/2021
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| Date Current Protocol Accepted |
12/19/2022
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| Study Name |
Patient Specific Talus Spacer PAS
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| Device Name |
Patient Specific Talus Spacer
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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 |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study objective is to evaluate the continued safety and probable benefit of the Talus Spacer in commercial use. The Patient Specific Talus Spacer PAS is a prospective, single-arm, multicenter US observational study to provide ongoing safety and probable benefit assessment of the Patient Specific Talus Spacer in treatment of avascular necrosis of the ankle.
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| Study Population |
50 adult subjects who have been diagnosed with avascular necrosis (AVN) in the ankle joint
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| Sample Size |
A minimum number of 50 patients will be enrolled in this study. Of the 50 subjects, a minimum of 20 subjects will receive a Cobalt Chromium Patient Specific Talus Spacer and a minimum of 20 subjects will receive a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer. The total sample size is based on both the safety and probable benefit hypotheses, accounts for 10% lost-to-follow-up, and ensures 90% statistical power using an unadjusted chi-square test with a 1-sided type 1 error rate of a = 0.05. The failure rate with device removal or serious device-related adverse event by Year 5 of the patient specific talus spacer is assumed to be lower than the failure rate with a non-union of the comparator, tibiotalocalcaneal fusion with allograft. For patients without failure, a >=20-point improvement on a 100-point scale for the Visual Analog Scale (VAS) pain scale at 5 years compared to baseline is assumed. The sample size for each material group is determined to ensure statistical power for the subgroup analysis.
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| Key Study Endpoints |
Primary Probable Benefit Endpoint:
The primary probable benefit endpoint is a clinically significant improvement in pain, as demonstrated by a = 20-point improvement on a 100-point scale for the Visual Analog Scale (VAS) pain scale at 5 years compared to baseline. Patients who undergo an SSSI will be defined as probable benefit endpoint failures. Therefore, a patient will achieve the primary probable benefit endpoint only if they do not undergo an SSSI and they achieve a = 20-point improvement in VAS pain.
Primary Safety Endpoint:
Based on the need for a subsequent secondary surgical intervention (SSSI) or Device Related Serious Adverse Events (“SAEs”) at 5 years post-procedure.
The following secondary safety endpoints will also be assessed:
• Adverse events (“AEs”)
• Device - or procedure related AEs
• Serious AEs (“SAEs”)
Additional Analyses:
Improvement at 5 years post-procedure compared to Pre-op on:
• Ankle ROM;
• FAOS for:
a. Pain
b. Symptom
c. Sport/Rec
d. Activities of Daily Living (“ADL”); and
e. Quality of Life (“QoL”)
Other Exploratory Analyses:
• X-ray Assessment and Measurements:
a. Tibiotalar Alignment
b. Talar Tilt Angle
c. Boehler’s Angle
d. Talar declination angle
e. Meary’s angle
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
•
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| Actual Number of Patients Enrolled |
18
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
Follow-up Rate: 100% (4 actual patients / 4 expected patients)
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| Final Safety Findings |
One (1) non-device related serious adverse event. There were no reported Subsequent Surgical Interventions.
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| Final Effect Findings |
Mean improvement in Visual Analog Scale (Scale) for pain observed at 12 months compared to preop [Mean=28.5 (SD=34.8) at 6 Months vs. Mean = 64.1 (SD=17.9) at Preop]
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