RecruitingNCT05067543

Perform Humeral System Study


Sponsor

Stryker Trauma and Extremities

Enrollment

300 participants

Start Date

Sep 12, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients who receive a shoulder replacement using the Perform Humeral System, a specific shoulder arthroplasty implant. Researchers will collect data on safety, how well the implant performs, and how patients' quality of life and shoulder function improve over time. You may be eligible if: - You are 18 years or older - You are scheduled for shoulder replacement surgery (arthroplasty) using this specific implant - You are willing to comply with all study visits and procedures - You meet the clinical indications for shoulder arthroplasty You may NOT be eligible if: - You have an active local or systemic infection, or bone infection (osteomyelitis) - You have poor bone quality that could result in implant failure or fracture - You have significant nerve damage (brachial plexus injury) or neuromuscular disease - You have a known allergy to any materials in the implant - You have metabolic disorders that impair bone formation - You are pregnant - You are planning a two-stage surgery procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETornier Perform Humeral - Stem

The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.


Locations(10)

Baptist Healthcare

Lexington, Kentucky, United States

Summit Orthopedics

Eagan, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Orthopedic Institute

Sioux Falls, South Dakota, United States

University of Utah

Salt Lake City, Utah, United States

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, Canada

Orthopedic Center Santy

Lyon, France

Schulthess Klinik

Zurich, Switzerland

Wrightington Hospital

Wigan, Lancashire, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05067543


Related Trials