Clinical trial NCT05067543: Perform Humeral System Study
Official title: Perform Humeral System Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis Shoulder
Avascular Necrosis
Post-traumatic Arthrosis of Other Joints, Shoulder Region
Rotator Cuff Tear Arthropathy
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intended for the total or partial replacement of the glenohumeral articulation.

Brief summary: 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.

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

Primary outcomes:
measure: Change from Baseline to last follow-up visit in ASES scores
timeFrame: Baseline through Follow-Up visits through 24 months Post-Op
Secondary outcomes:
measure: Change from Baseline to last follow-up visit in Constant Murley scores
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in SANE scores
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in Subject Satisfaction scores
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Change from Baseline to last follow-up visit in EQ-5D scores
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Number of device associated and procedure associated adverse events.
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Rates of revision surgeries.
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
measure: Evaluation of radiological imaging of the affected shoulder
timeFrame: Baseline through Follow-Up visits through 10 years Post-Op
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Baptist Healthcare
state: Kentucky
city: Eagan
country: United States
facility: Summit Orthopedics
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Sioux Falls
country: United States
facility: Orthopedic Institute
state: South Dakota
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: London
country: Canada
facility: Roth McFarlane Hand and Upper Limb Centre
state: Ontario
city: Lyon
country: France
facility: Orthopedic Center Santy
city: Zürich
country: Switzerland
facility: Schulthess Klinik
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
Study officials:
affiliation: Stryker Trauma
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: