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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190009 / PAS001 |
| Date Original Protocol Accepted |
02/12/2021
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| Date Current Protocol Accepted |
|
| Study Name |
TFAOS 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 |
Other Data Source
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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 Transfemoral Amputation Osseointegration Study (TFAOS) initiated on November 11, 2017 and is sponsored by the Henry Jackson Foundation. The sponsor of TFAOS has agreed to provide the data to Integrum, who will analyze the data consistent with FDA’s requested endpoints and then submit reports to the agency.
The TFAOS is a prospective, multicenter, cohort study to provide an ongoing assessment of the short-term (2 years) safety and effectiveness outcomes of the updated version of the OPRATM Implant system (e.g., improvements with components, AxorTM II, and instrumentation since the H080004 pivotal study).
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| Study Population |
Patients who have the OPRATM implant procedure performed at Walter Reed or Univeristy of California San Francisco (UCSF) and meet the eligibility criteria established in the study protocol.
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| Sample Size |
The sample size of 50 patients in the TFAOS study was calculated to power the primary endpoint in the study, i.e., the change in prosthetic use score. A sample size of 50 patients is also sufficient for the primary endpoints in the PAS analysis. With an alpha of 0.05, 50 subjects have >80% power to demonstrate that each primary endpoint result will be greater than 50%, assuming 70% success.
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| Key Study Endpoints |
Primary Endpoints
1. Rate of overall success at 2 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.
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 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 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 |
2 years after Stage 2 Surgery
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
50 subjects enrolled (Walter Reed: 41 subjects; UCSF: 9 subjects)
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| Actual Number of Sites Enrolled |
2 sites enrolled
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| Patient Follow-up Rate |
Walter Reed: enrolled: 41, completed 37 (90.2%) All subjects have had stage 1 surgery, and 40 of 41 subjects have completed stage 2
surgery. Four subjects have been withdrawn from Walter Reed (Table below shows reason). UCSF: 9 subjects enrolled, 4 subjects
completed. All subjects have had stage 1 surgery, 8 have completed stage 2 surgery, and 4 subjects have completed the study. There are
ZERO withdrawn subjects at UCSF.
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| Final Safety Findings |
No serious or unanticipated adverse events were reported during this reporting period
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| Final Effect Findings |
The available data (preliminary results) to date demonstrate the safety and effectiveness of the OPRA device approved in the PMA.
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