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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
H230003 / PAS001 |
| Date Original Protocol Accepted |
01/12/2024
|
| Date Current Protocol Accepted |
04/05/2024
|
| Study Name |
Total Talus Replacement (TTR) PAS
|
| Device Name |
restor3d Total Talus Replacement
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Study Design: Multicenter, single arm, prospective, post-approval study
Study Objective: The objective of this study is to provide ongoing safety and probable benefit assessment of the restor3d TTR implant through evaluation of clinical and radiographic data.
|
| Study Population |
Adults (greater than or equal to 22 years of age) who have received a restor3d Total Talus Replacement device under an approved HDE for one of the indications listed on the Instructions for Use (IFU) and who do not have a contraindication.
|
| Sample Size |
50 subjects will be enrolled in this post approval study. The study will include a minimum of 5 US centers, with a maximum of 20 patients at any 1 site.
|
| Key Study Endpoints |
Primary Endpoint: A composite endpoint will be used to evaluate safety and probable benefit of the TTR device at 5 years.
• Safety: Absence of a subsequent secondary surgical intervention (SSSI) and a device-related serious adverse event (SAE) on the affected joints at 5 years.
• Probable Benefit: Joint salvage with the restor3d device still in place at 5 years
Secondary Endpoints (evaluated based on comparison of postoperative scores to baseline scores):
Safety:
• Procedure-related SAE at 5 years post implantation
• Device or procedure related adverse events (AEs)
Probable Benefit:
• Pain improvement on the 11 – point Pain Numeric Rating Scale (NRS)
• Improvement of maintenance in Ankle Range of Motion (ROM)
• Improvement in Foot and Ankle Outcome Scores (FAOS)-Composite
• Improvement in FAOS – Subscale, individually, on the following subscales
o Pain subscale
o Symptoms subscale
o Sports/Recreation subscale
o Quality of Life (QoL) subscale
o Activities of Daily Living (ADL) subscale
Exploratory Endpoints:
• The following x-ray assessments will be performed to evaluate:
o Presence of adverse events, proper location of implant without migration, absence of subsidence into calcaneus, and health of surrounding soft tissue
o Tibiotalar Alignment
o Talar Tilt Angle
o Boehler’s Angle
o Talar declination angle
o Meary’s angle.
• Soft tissue attachment sites will be defined as the number of cases provided with soft tissue attachment sites and the number of cases where soft tissue attachment sites were used. Device-related AEs and SAEs will be analyzed to determine if there is a relationship between use of the soft tissue attachment site and the rate of AE/SAE occurrences.
• Preference questions (e.g., if the patient would choose to undergo this procedure again if given the option) will be asked to participants, annually.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
