Evaluation of the PERFORM™ Humeral System for shoulder conditions
Perform Humeral System Study
This study is testing how safe and effective the PERFORM™ Humeral System is for people who have had shoulder surgery by tracking their recovery and quality of life over the next ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stryker Trauma and Extremities Industry-sponsored |
| Locations | 10 sites (Lexington, Kentucky and 9 other locations) |
| Trial ID | NCT05067543 on ClinicalTrials.gov |
What this trial studies
This international, multicenter observational study aims to collect safety and performance data on the PERFORM™ Humeral System after shoulder arthroplasty. Participants will be monitored at baseline, immediately post-operation, and annually for up to 10 years. The study will utilize Patient Reported Outcome Measures to assess quality of life, pain, functional improvements, and safety of the implants, alongside radiographic evaluations. The data gathered will support post-market surveillance and contribute to regulatory submissions and educational materials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are considered suitable for shoulder arthroplasty using the PERFORM™ Humeral System.
Not a fit: Patients who are unable to comply with study procedures or belong to vulnerable groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of the PERFORM™ Humeral System, potentially leading to improved treatment options for patients with shoulder conditions.
How similar studies have performed: While this study is focused on a specific device, similar observational studies have shown success in evaluating post-market performance of orthopedic implants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older at the time of the informed consent or non-opposition (when applicable). * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable). * Willing and able to comply with the requirements of the study protocol. * Considered a candidate for shoulder arthroplasty using a study device. * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements Exclusion Criteria: * Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times) * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm). * Active local or systemic infection, sepsis, or osteomyelitis * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid * Significant injury to the brachial plexus * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components * Neuromuscular disease (e.g., joint neuropathy) * Patient with known allergy to one of the product materials * Metabolic disorders which may impair bone formation * Patient pregnancy * Planned for two-stage surgery
Where this trial is running
Lexington, Kentucky and 9 other locations
- Baptist Healthcare — Lexington, Kentucky, United States (Recruiting)
- Summit Orthopedics — Eagan, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Terminated)
- Washington University — St Louis, Missouri, United States (Active_not_recruiting)
- Orthopedic Institute — Sioux Falls, South Dakota, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Roth McFarlane Hand and Upper Limb Centre — London, Ontario, Canada (Active_not_recruiting)
- Orthopedic Center Santy — Lyon, France (Active_not_recruiting)
- Schulthess Klinik — Zurich, Switzerland (Active_not_recruiting)
- Wrightington Hospital — Wigan, Lancashire, United Kingdom (Active_not_recruiting)
Study contacts
- Study coordinator: Meredith Schreier
- Email: meredith.schreier@stryker.com
- Phone: 901-232-2704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.