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Sponsor business decision
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder Arthroplasty | Device | Data will be collected for commercially available Sponsor devices. These systems treat both the humeral and glenoid side of the shoulder joint. The following products will be included in the study in the geographies where they are commercially available.
Devices previously included, but discontinued under clinical investigation plan (CIP) version 4.0:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first revision surgery | Time from primary study surgery to revision surgery | up to 10 years |
| Change from baseline and previous visit in ASES scores | ASES Score = American Shoulder and Elbow Surgeons Score |
Inclusion Criteria:
Exclusion Criteria:
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Patients from United States and Europe
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma & Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| California Pacific Orthopaedics |
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| at 1, 2, 5, 7, and 10 years of follow-up |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| San Francisco |
| California |
| 94115 |
| United States |
| Western Orthopaedics | Denver | Colorado | 80218 | United States |
| Resurgens Orthopaedics | Atlanta | Georgia | 30342 | United States |
| University of Iowa Sports Medicine Clinic | Iowa City | Iowa | 52242 | United States |
| Lexington Clinic Orthopedics - Sports Medicine Center | Lexington | Kentucky | 40504 | United States |
| Great Lakes Orthopaedic Center | Traverse City | Michigan | 49684 | United States |
| Allina Health Orthopedics | Edina | Minnesota | 55439 | United States |
| University of MO - Columbia | Columbia | Missouri | 65212 | United States |
| Jersey Medical Center | Jersey City | New Jersey | 07030 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Rothman Institute Orthopaedics | Philadelphia | Pennsylvania | 19107 | United States |
| Ascension Medical Group Seton Orthopedics | Austin | Texas | 78758 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Fondren Orthopedic Group | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D000072228 | Arthroplasty, Replacement, Shoulder |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
| D005592 | Fracture Fixation |
| D013812 | Therapeutics |
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