This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
For total ankle replacement
The CORE Institute
Phoenix, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Palo Alto Medical Research Foundation (Sutter Health)
Palo Alto, California, United States
Primary Endpoint
The primary objective of this study is to examine the performance of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The principal endpoint consists of evaluating the safety and effectiveness of the STAR™ Ankle. Overall patient success is defined as: 1. ≥ 40 point improvement in total Buechel-Pappas Scale score 2. No device failures 3. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration \> 4mm) 4. No major complications
Time frame: 2 years
Secondary Endpoints
In addition to the principal endpoint, information on the following efficacy outcomes will be assessed: * Total Buechel-Pappas Scale score * Pain Visual Analog Scale * Quality of Life * American Orthopaedic Foot \& Ankle Society (AOFAS) Ankle Hindfoot Scale The following radiographic endpoints will be assessed by anterior/posterior and lateral radiographs by the treating surgeon and an independent radiographic reviewer: * Radiolucency * Migration
Time frame: 2 years
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Kaiser Permanente
San Francisco, California, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Reno Orthopaedic Center
Reno, Nevada, United States
Kenneth Mroczek, MD-NYU
New York, New York, United States
University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
Philadelphia, Pennsylvania, United States
Center for Foot and Ankle Restoration
Dallas, Texas, United States