NCT02047955

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

Tornier Shoulder Outcomes Clinical Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7,500 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Shoulder Arthroplasty and Fracture Repair

Interventions

Type	Name	Description
DEVICE	Shoulder 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

Timeline

• Start date: 2014-03-01
• Primary completion: 2024-09-12
• Completion: 2024-10-16
• First posted: 2014-01-29
• Last updated: 2025-05-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study