Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients

N/ATerminatedNCT02047955

Stryker Trauma and Extremities7,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

7,500

Conditions

Shoulder Arthroplasty and Fracture Repair

Interventions

Shoulder ArthroplastyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (15)

University of Alabama at Birmingham

Birmingham, Alabama, United States

California Pacific Orthopaedics

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 10 years

Secondary Outcomes

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.

Time frame: up to 10 years

Data from ClinicalTrials.gov

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