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NCT05067543 | RECRUITING | Osteoarthritis Shoulder

Perform Humeral System Study
Sponsor:

Stryker Trauma and Extremities

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.

Condition or disease

Osteoarthritis Shoulder

Avascular Necrosis

Post-traumatic Arthrosis of Other Joints, Shoulder Region

Rotator Cuff Tear Arthropathy

Intervention/treatment

Tornier Perform Humeral - Stem

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : Perform Humeral System Study
Actual Study Start Date : 2021-09-12
Estimated Primary Completion Date : 2035-06-30
Estimated Study Completion Date : 2035-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
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
Perform Humeral System Study

Location Details

NCT05067543

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Kentucky

Baptist Healthcare

Lexington, Kentucky, United States, 40503

TERMINATED

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Missouri

Washington University

St. Louis, Missouri, United States, 63110

RECRUITING

United States, South Dakota

Orthopedic Institute

Sioux Falls, South Dakota, United States, 57105

RECRUITING

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84108

RECRUITING

Canada, Ontario

Roth McFarlane Hand and Upper Limb Centre

London, Ontario, Canada, N6A 4L6

RECRUITING

France,

Orthopedic Center Santy

Lyon, France, 69008

RECRUITING

Switzerland,

Schulthess Clinic

Zürich, Switzerland, CH-8008

RECRUITING

United Kingdom, Lancashire

Wrightington Hospital

Wigan, Lancashire, United Kingdom, And pouring water