Shoulder Arthroplasty and Fracture Repair Clinical Trial
Official title:
Tornier Shoulder Outcomes Clinical Study
| Verified date | April 2024 |
| Source | Stryker Trauma GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 7500 |
| Est. completion date | January 2032 |
| Est. primary completion date | January 2032 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Resurgens Orthopaedics | Atlanta | Georgia |
| United States | Ascension Medical Group Seton Orthopedics | Austin | Texas |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | University of MO - Columbia | Columbia | Missouri |
| United States | UT Southwestern | Dallas | Texas |
| United States | Western Orthopaedics | Denver | Colorado |
| United States | Duke University | Durham | North Carolina |
| United States | Allina Health Orthopedics | Edina | Minnesota |
| United States | Fondren Orthopedic Group | Houston | Texas |
| United States | University of Iowa Sports Medicine Clinic | Iowa City | Iowa |
| United States | Jersey Medical Center | Jersey City | New Jersey |
| United States | Lexington Clinic Orthopedics - Sports Medicine Center | Lexington | Kentucky |
| United States | Rothman Institute Orthopaedics | Philadelphia | Pennsylvania |
| United States | California Pacific Orthopaedics | San Francisco | California |
| United States | Great Lakes Orthopaedic Center | Traverse City | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Stryker Trauma GmbH |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time to first revision surgery | Time from primary study surgery to revision surgery | up to 10 years | |
| Other | Change from baseline and previous visit in ASES scores | ASES Score = American Shoulder and Elbow Surgeons Score | at 1, 2, 5, 7, and 10 years of follow-up | |
| Other | Constant Score | The total score by visit and the within subject score changes of the Constant Total Score from visit to visit will be analyzed to help identify the changes on the subject level. This analysis will be part of the final report. | at 1, 2, 5, 7, and 10 years of follow-up | |
| Other | Change from baseline and previous visit in SANE scores | SANE = Single Assessment Numeric Evaluation | at 1, 2, 5, 7, 10, 15, and 20 years follow-up | |
| Other | Subject Satisfaction | The total score by visit and the within subject score changes of the Patient Satisfaction Score from visit to visit will be analyzed to help identify the changes on the subject level (assessed as improved, worsened or no change). This analysis will be part of the final report. | at 1, 2, 5, 7, and 10 years of follow-up | |
| Other | Cumulative incidence of migration, radiolucency, osteolysis, and bone wear | as assessed by available X-ray, CT, or MRI | at 1, 2, 5, 7, and 10 years of follow-up | |
| Other | EQ-5D-5L | The total score by visit and the within subject score changes of the EQ-5D-5L from visit to visit will be analyzed to help identify the changes on the subject level (assessed as improved, worsened or no change). This analysis will be part of the final report. | at 1, 2, 5, 7, and 10 years of follow-up | |
| Primary | Number of device associated and procedure associated adverse events | 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. | up to 10 years | |
| Secondary | Rates of reoperation and revision surgery | 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. | up to 10 years |