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

NCT02047955 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7500

Last updated 2025-05-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma & Extremities

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2024-09-12
Completion
2024-10-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02047955 on ClinicalTrials.gov