Actively Recruiting

Age: 18Years +
All Genders
NCT05067543

Perform Humeral System Study

Led by Stryker Trauma and Extremities · Updated on 2026-02-20

300

Participants Needed

10

Research Sites

794 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Perform Humeral System Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older at the time of informed consent or non-opposition
  • Able and willing to sign an informed consent form approved by IRB or EC
  • Willing and able to follow study protocol requirements
  • Considered a candidate for shoulder arthroplasty using the study device
  • Meets local, regional, or geographic regulatory requirements for use of the device
Not Eligible

You will not qualify if you...

  • Unable to comply with study procedures (e.g., cannot understand questions or keep scheduled visits)
  • Belongs to a vulnerable patient group needing special protections or legally authorized representative
  • Active local or systemic infection, sepsis, or osteomyelitis
  • Poor bone quality risking prosthesis migration or humerus/glenoid fracture
  • Significant injury to the brachial plexus
  • Inadequate bone stock in proximal humerus or glenoid fossa
  • Neuromuscular diseases affecting joints
  • Known allergy to any product materials
  • Metabolic disorders impairing bone formation
  • Pregnancy
  • Planned for two-stage surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Baptist Healthcare

Lexington, Kentucky, United States, 40503

Actively Recruiting

2

Summit Orthopedics

Eagan, Minnesota, United States, 55121

Actively Recruiting

3

Mayo Clinic

Rochester, Minnesota, United States, 55905

Terminated

4

Washington University

St Louis, Missouri, United States, 63110

Active, Not Recruiting

5

Orthopedic Institute

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

6

University of Utah

Salt Lake City, Utah, United States, 84108

Actively Recruiting

7

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, Canada, N6A 4L6

Active, Not Recruiting

8

Orthopedic Center Santy

Lyon, France, 69008

Active, Not Recruiting

9

Schulthess Klinik

Zurich, Switzerland, CH-8008

Active, Not Recruiting

10

Wrightington Hospital

Wigan, Lancashire, United Kingdom, WN6 9EP

Active, Not Recruiting

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Research Team

M

Meredith Schreier

CONTACT

A

Amjad Uneisi

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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