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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P190009 / PAS002 |
| Date Original Protocol Accepted |
02/12/2021
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| Date Current Protocol Accepted |
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| Study Name |
Osseointegration Quality Registry PAS
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| Device Name |
OPRA Implant System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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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 objective of this study is to investigate the 2-year and 5-year safety and effectiveness outcomes of the OPRA device.
The Osseointegration Quality Registry is a prospective registry sponsored by Walter Reed and conducted at all sites that consent to collect data for the registry. The registry study initiated on February 11, 2019 and is sponsored by the Walter Reed. The sponsor of the registry has agreed to provide the OPRA-related data to Integrum, who will analyze the data consistent with FDA’s requested endpoints and then submit reports to the agency. The other PAS, Transfemoral Amputation Osseointegration Study (TFAOS), is a 2-year study. Patients who agree to be followed for 5 years after completion in TFAOS will be transitioned to this registry.
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| Study Population |
Patients who have the OPRATM implant procedure and meet the eligibility criteria. The study is being conducted at Walter Reed and is offered to all US sites that perform the OPRA implant procedure.
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| Sample Size |
100 subjects will be enrolled in the PAS registry. Up to 50 subjects will be from the other PAS study, TFAOS.
The sample size in the TFAOS study was calculated to power the primary endpoint in that study, which is the change in prosthetic use score.
A sample size of 100 patients is also sufficient for the primary endpoints in the PAS analysis. With an alpha of 0.05, 100 subjects have >98% power to demonstrate that each primary endpoint result will be greater than 50%, assuming 70% success and a power of 86% assuming 65% success.
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| Key Study Endpoints |
Primary Endpoints
1. Rate of overall success at 2 years and 5 years. The overall success is the composite primary safety and effectiveness endpoint.
a. Primary safety endpoint: Proportion of patients with no subsequent secondary surgical interventions and, at most, 2 superficial infections, at 2 years. and, no subsequent secondary surgical interventions and at most 3 superficial infections at 5 years.
b. Primary effectiveness endpoint: Proportion of patients who achieve the minimally clinically important difference (MCID) for the total Q-TFA score (mean of all subscores, i.e., prosthetic use score, prosthetic mobility score, problem score, and global score) of 20.25 points, and radiographic success, defined as no radiographic loosening of the implant with a radiolucent zone wider than the thread depth surrounding the entire implant.
2. Proportion of patients who achieved either/or/none of primary safety endpoint or primary effectiveness endpoint at 2 and 5 years.
Secondary Endpoints
Proportion of patients who achieved the MCID for the Q-TFA prosthetic use score (19 points), prosthetic mobility score (11 points), problem score (-23 points), and global score (33 points), individually at 2 and 5 years after stage-2 surgery.
Change in each of total Q-TFA score, Q-TFA prosthetic use score, prosthetic mobility score, problem score and global score from baseline to 2 years after stage-2 surgery.
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| Follow-up Visits and Length of Follow-up |
5 years after stage-2 surgery
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| Interim or Final Data Summary |
| Interim Results |
No serious or unanticipated adverse events were reported during this reporting period.
The available data (preliminary results) to date demonstrate the safety and effectiveness of the OPRA device approved in the PMA.
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| Actual Number of Patients Enrolled |
90 subjects enrolled (Walter Reed: n=55 subjects, UCSF: n=17 subjects, Atrium Health: n=16 subjects, Brigham and Women's Hospital: n=2 subjects)
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| Actual Number of Sites Enrolled |
7 sites enrolled
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| Patient Follow-up Rate |
Walter Reed: 69% (38 subjects completed the study/55 subjects enrolled)
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| Study Strengths & Weaknesses |
will be included in final report
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