Stryker Trauma and Extremities
This study is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF), which is designed to collect safety and performance data on commercially available Perform® Fracture. Data collected from this study will be used for purposes, including but not limited to, PMS, peer-reviewed publications, education materials, future regulatory submissions, and/or product development.
Traumatic Arthropathy of Shoulder
Fracture Humerus
Traumatic Arthritis
Revision of Other Devices if Sufficient Bone Stock Remains
Tornier Perform® Humeral System - Fracture
This is an International, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Perform® Fracture shoulder system in both the anatomic and reversed configurations. The primary endpoint of this study is to demonstrate decreased pain and improved subjects' shoulder functionality of daily living by achieving a mean of American Shoulder and Elbow Surgeons (ASES) shoulder score higher than 62 points, at 2-year follow-up post-operatively, regardless of configuration (anatomic or reverse). Retrospective inclusions are allowed: preoperative and intra operative data can be collected retrospectively up to 2 months after the surgery date. Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: bone erosion, device migration/subsidence, component breakage, radiolucency, and ossification. Safety and performance data will be collected at surgery, immediate post-op, and up to 10 years post-operation. Patient Reported Outcome Measures (PROMs), device revision and Adverse Events (AEs) will be assessed annually throughout the study. Range of Motion (ROM), strength and radiographic imaging assessments of the study shoulder will also be performed for in-person milestones visits at 6 months (radiographic imaging assessments), 1-, 2-, 5- and 10-year, post-operatively.
Study Type : | OBSERVATIONAL |
Estimated Enrollment : | 120 participants |
Official Title : | Tornier Perform® Humeral System - Fracture Study |
Actual Study Start Date : | 2023-08-31 |
Estimated Primary Completion Date : | 2028-09-01 |
Estimated Study Completion Date : | 2033-09-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
More Foundation
Phoenix, arizona, United States, 85023
RECRUITING
University of Arkansas Medical Sciences
Little Rock, arkansas, United States, 72205
RECRUITING
Eisenhower Health Desert Orthopedic Center
Rancho Mirage, California, United States, 92270
RECRUITING
California Pacific Orthopaedics
San Francisco, California, United States, 94118
RECRUITING
Washington University
St. Louis, Missouri, United States, 63110
RECRUITING
Tennessee Orthopaedic Alliance
Columbia, Tennessee, United States, 38401
RECRUITING
University of Texas/UT Health
Houston, Texas, United States, 77030