Perform Humeral System Study
Recruiting · NCT05067543 · Observational (researchers observe without assigning treatment) · Lead sponsor: Stryker Trauma and Extremities
View the official record on ClinicalTrials.gov →Interventions studied
Tornier Perform Humeral - Stem
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
11 locations listed across 6 US states.
- 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
- Ohio State University - Columbus, Ohio, United States
- Orthopedic Institute - Sioux Falls, South Dakota, United States
- University of Utah - Salt Lake City, Utah, United States
- Orthopedic Center Santy - Lyon, France
- Schulthess Klinik - Zurich, Switzerland
- Wrightington Hospital - Wigan, Lancashire, United Kingdom
- Roth McFarlane Hand and Upper Limb Centre - London, Ontario, Canada