Tornier Shoulder Outcomes Clinical Study

Stryker Trauma and Extremities15 sites in 1 country7,500 target enrollmentMarch 2014

ConditionsShoulder Arthroplasty and Fracture Repair

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shoulder Arthroplasty and Fracture Repair
Sponsor: Stryker Trauma and Extremities
Enrollment: 7500
Locations: 15
Primary Endpoint: Number of device associated and procedure associated adverse events
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

October 16, 2024

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stryker Trauma and Extremities

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Number of device associated and procedure associated adverse events

Time Frame: 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.