Shoulder Arthroplasty and Fracture Repair
Conditions
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.
Interventions
DEVICEShoulder Arthroplasty
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. * Aequalis Ascend Flex Convertible Shoulder System * Pyrocarbon Humeral Head (used with Aequalis Ascend Flex) * Simpliciti Shoulder Prosthesis * Aequalis Reversed Fracture Prosthesis * Aequalis PerFORM Glenoid * Aequalis PerFORM+ Glenoid * Aequalis PerFORM Reversed Glenoid Devices previously included, but discontinued under clinical investigation plan (CIP) version 4.0: * Aequalis Resurfacing Head * Aequalis Ascend Anatomic Shoulder System * Aequalis IM Humeral Nail - Short and Long * ORTHOLOC™ SPS (Shoulder Plating System) * Aequalis Reversed II Shoulder System * Aequalis Adjustable Reversed Prosthesis * Aequalis Flex Revive Shoulder System
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline and previous visit in ASES scores | at 1, 2, 5, 7, and 10 years of follow-up | ASES Score = American Shoulder and Elbow Surgeons Score |
| Constant Score | at 1, 2, 5, 7, and 10 years of follow-up | 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. |
| Change from baseline and previous visit in SANE scores | at 1, 2, 5, 7, 10, 15, and 20 years follow-up | SANE = Single Assessment Numeric Evaluation |
| Subject Satisfaction | at 1, 2, 5, 7, and 10 years of follow-up | 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. |
| Cumulative incidence of migration, radiolucency, osteolysis, and bone wear | at 1, 2, 5, 7, and 10 years of follow-up | as assessed by available X-ray, CT, or MRI |
| EQ-5D-5L | at 1, 2, 5, 7, and 10 years of follow-up | 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. |
| Time to first revision surgery | up to 10 years | Time from primary study surgery to revision surgery |
Countries
United States
Outcome results
None listed