Perform Humeral System Study
Key facts
- Where
- London, CanadaSee the site
Where in Canada
- Roth McFarlane Hand and Upper Limb CentreLondon, CanadaContact: Amjad UneisiNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Stryker Trauma and Extremities
- Trial code
- NCT05067543
- Record updated
- 1 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Planned for two-stage surgery; Active local or systemic infection, sepsis, or osteomyelitis; Neuromuscular disease (e.g., joint neuropathy); Patient with known allergy to one of the product materials; Metabolic disorders which may impair bone formation; 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); 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; Patient pregnancy.