Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
- Conditions
- Shoulder Arthroplasty and Fracture Repair
- Registration Number
- NCT02047955
- Lead Sponsor
- Stryker Trauma and Extremities
- Brief Summary
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7500
- 18 years or older
- Willing and able to comply with the requirements of the study protocol
- Considered for treatment with one or more Tornier shoulder arthroplasty or fracture devices included in this study
- Patients who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of device associated and procedure associated adverse events up to 10 years Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.
- Secondary Outcome Measures
Name Time Method Rates of reoperation and revision surgery up to 10 years The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival at the end of the clinical investigation.
Trial Locations
- Locations (15)
Rothman Institute Orthopaedics
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
California Pacific Orthopaedics
🇺🇸San Francisco, California, United States
Western Orthopaedics
🇺🇸Denver, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States
Great Lakes Orthopaedic Center
🇺🇸Traverse City, Michigan, United States
University of MO - Columbia
🇺🇸Columbia, Missouri, United States
Resurgens Orthopaedics
🇺🇸Atlanta, Georgia, United States
Fondren Orthopedic Group
🇺🇸Houston, Texas, United States
Allina Health Orthopedics
🇺🇸Edina, Minnesota, United States
University of Iowa Sports Medicine Clinic
🇺🇸Iowa City, Iowa, United States
Lexington Clinic Orthopedics - Sports Medicine Center
🇺🇸Lexington, Kentucky, United States
Ascension Medical Group Seton Orthopedics
🇺🇸Austin, Texas, United States
Jersey Medical Center
🇺🇸Jersey City, New Jersey, United States