Perform Humeral System Study

Last updated: October 14, 2024
Sponsor: Stryker Trauma and Extremities
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

Tornier Perform Humeral - Stem

Clinical Study ID

NCT05067543
20D-W-PHS-RM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older at the time of the informed consent or non-opposition (whenapplicable).

  • Informed and willing to sign an informed consent form approved by IRB or EC (whenapplicable).

  • 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 geographicspecific regulatory requirements

Exclusion

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 assessmenttimes)

  • Patient belongs to a vulnerable group of patients, including minor patients, thoseunable to decide for themselves to participate or needing a Legally AuthorizedRepresentative (LAR), or others who could be subject to coercion (patients who maynot be acting on their own initiative) (referred as "vulnerable subject" in thesection 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 prothesisand/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 thecomponents

  • 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

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Tornier Perform Humeral - Stem
Phase:
Study Start date:
September 12, 2021
Estimated Completion Date:
December 01, 2035

Study 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.

Connect with a study center

  • Roth McFarlane Hand and Upper Limb Centre

    London, Ontario N6A 4L6
    Canada

    Active - Recruiting

  • Orthopedic Center Santy

    Lyon, 69008
    France

    Active - Recruiting

  • Schulthess Klinik

    Zürich, CH-8008
    Switzerland

    Active - Recruiting

  • Wrightington Hospital

    Wigan, Lancashire WN6 9EP
    United Kingdom

    Active - Recruiting

  • Baptist Healthcare

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Summit Orthopedics

    Eagan, Minnesota 55121
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Terminated

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Orthopedic Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

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