Actively Recruiting
Perform Humeral System Study for Shoulder Arthroplasty Using the Tornier Perform Humeral Stem Device
Led by Stryker Trauma and Extremities · Updated on 2026-02-20
300
Participants Needed
10
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect safety and performance data on the PERFORM20 Humeral System, a device used for partial or total shoulder replacement in patients with conditions such as osteoarthritis, avascular necrosis, post-traumatic arthrosis of the shoulder region, and rotator cuff tear arthropathy. It is an international, single-arm, multicenter, prospective post-market clinical follow-up study designed to evaluate patient outcomes over time. The study focuses on patient-reported measures related to quality of life, pain, and function, as well as safety and radiographic assessments. Participants will undergo shoulder arthroplasty using the Tornier Perform Humeral Stem device. Data will be collected at baseline, during surgery, immediately after surgery, and then annually for up to 10 years post-operation. The study monitors the device's safety and performance through various assessments including patient satisfaction and radiological imaging throughout the follow-up period. During the study, participants will be assessed using patient-reported outcome measures such as ASES, Constant Murley, SANE, Subject Satisfaction, and EQ-5D scores from baseline through follow-up visits up to 10 years. Researchers will also track adverse events, revision surgeries, and imaging evaluations of the shoulder. The study involves long-term monitoring to understand the safety and effectiveness of the implant over time.
CONDITIONS
Brief Title
Perform Humeral System Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of informed consent or non-opposition when applicable
- Willing and able to sign an informed consent form approved by IRB or EC when applicable
- Willing and able to comply with study protocol requirements
- Considered a candidate for shoulder arthroplasty using the study device
- Meets indications for use or other local, regional, or geographic regulatory requirements
You will not qualify if you...
- Unable to comply with study procedures (e.g., cannot understand study questions or keep assessment schedules)
- Belongs to a vulnerable group (minors, legally incapacitated, or others subject to coercion)
- Active local or systemic infection, sepsis, or osteomyelitis
- Poor bone quality risking prosthesis migration or fracture
- Significant injury to the brachial plexus
- Inadequate bone stock in proximal humerus or glenoid fossa
- Neuromuscular disease such as joint neuropathy
- Known allergy to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem device.
1 surgical visit (in-person)
Duration - Up to 10 years post-implantation
Participants are followed to assess safety, device performance, and quality of life through patient-reported outcome measures and radiographic assessments.
Regular follow-up visits over 10 years
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
Research Team
M
Meredith Schreier
A
Amjad Uneisi
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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