Perform Humeral System Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tornier Perform Humeral - Stem.
- Who it may be relevant to
- Registry conditions: Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, France, Switzerland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be collected for the commercially available PERFORM™ Humeral System. The objective of this study is to demonstrate the safety and performance of the PERFORM™ Humeral System devices after implantation over a standard follow-up period using Patient Reported Outcome Measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments. Safety and performance measures will be evaluated throughout the patient's participation in the study.
Interventions
- Device Tornier Perform Humeral - Stem
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
Primary outcome measures
- Change from Baseline to last follow-up visit in ASES scores [Time frame: Baseline through Follow-Up visits through 24 months Post-Op]
Secondary outcome measures (7)
- Change from Baseline to last follow-up visit in Constant Murley scores [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Change from Baseline to last follow-up visit in SANE scores [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Change from Baseline to last follow-up visit in Subject Satisfaction scores [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Change from Baseline to last follow-up visit in EQ-5D scores [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Number of device associated and procedure associated adverse events. [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Rates of revision surgeries. [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
- Evaluation of radiological imaging of the affected shoulder [Time frame: Baseline through Follow-Up visits through 10 years Post-Op]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 6 centers
- Baptist Healthcare — Lexington
- Summit Orthopedics — Eagan
- Mayo Clinic — Rochester
- Washington University — St Louis
- Orthopedic Institute — Sioux Falls
- University of Utah — Salt Lake City
Canada · 1 center
- Roth McFarlane Hand and Upper Limb Centre — London
France · 1 center
- Orthopedic Center Santy — Lyon
Switzerland · 1 center
- Schulthess Klinik — Zurich
United Kingdom · 1 center
- Wrightington Hospital — Wigan
Identifiers
NCT: NCT05067543 · 20D-W-PHS-RM