Perform Humeral System Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05067543
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stryker Trauma and Extremities
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rebecca Gibson
Principal Investigator Affiliation	Stryker Trauma
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy

Additional Details

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.

Arms & Interventions

Arms

: Tornier Perform Humeral System - Stem

Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baptist Healthcare, Lexington, Kentucky

Status

Recruiting

Address

Baptist Healthcare

Lexington, Kentucky, 40503

Site Contact

Dee Mallory

[email protected]

901-232-2704

Summit Orthopedics, Eagan, Minnesota

Status