Zimmer Biomet Shoulder Arthroplasty PMCF

Last updated: March 11, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Alliance Glenoid

Identity Stem

Clinical Study ID

NCT04984291
CMU2019-35E
  • Ages > 20
  • All Genders

Study Summary

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient must be 20 years of age or older.

  • Patient must be anatomically and structurally suited to receive shoulderarthroplasty implants.

  • Patient is a candidate for shoulder arthroplasty due to one or more of thefollowing:

  • Non-inflammatory degenerative joint disease including osteoarthritis andavascular necrosis.

  • Rheumatoid arthritis.

  • Correction of functional deformity.

  • Fractures of the proximal humerus, where other methods of treatment are deemedinadequate.

  • Difficult clinical management problems, where other methods of treatment maynot be suitable or may be inadequate.

  • Patient must be able and willing to complete the protocol required follow-up.

  • Patient must be able and willing to sign the IRB/EC approved informed consent.

  • Patient has grossly deficient rotator, (for reverse application)

  • With severe arthropathy and/or

  • Previously failed shoulder joint replacement

  • Patient must have functional deltoid muscle (for reverse application)

Exclusion

Exclusion Criteria:

  • Patient is unwilling or unable to give consent or to comply with the follow-upprogram.

  • Patient has any condition which would in the judgement of the Investigator, placethe patient at undue risk or interfere with the study.

  • Patient is known to be pregnant or breastfeeding.

  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, a known alcohol or drug abuser,and/or anticipated to be non-compliant).

  • Patient is uncooperative or patient with neurologic disorders who is incapable orunwilling to follow directions.

  • Patient has any sign of infection affecting the shoulder joint or in its proximitywhich may spread to the implant site.

  • Patient has rapid joint destruction, marked bone loss, or bone resorption apparenton roentgenogram.

  • Patient has any neuromuscular disease compromising the affected limb that wouldrender the procedure unjustifiable.

  • Patient presents with osteoporosis, which in the opinion of the Investigator, maylimit the subject's ability to support total shoulder arthroplasty using the studydevice.

  • Patient has osteomalacia.

  • Patient has a metabolic disorder that may impair bone formation.

  • Patient has deficient rotator cuff.

  • Patient presents with significant injury to the upper brachial plexus.

  • Patient has paralysis of the axillary nerve.

  • Patient has non-functional deltoid or external rotator muscles.

Study Design

Total Participants: 584
Treatment Group(s): 2
Primary Treatment: Alliance Glenoid
Phase:
Study Start date:
July 28, 2021
Estimated Completion Date:
August 15, 2033

Study Description

The primary endpoint is defined as survival of the implant at 10 years, which is based on removal or intended removal of at least 1-study implant component and will be determined by using the Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Separate analysis will be done for each arm of the study.

The secondary endpoint is represented by the performance and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation after 2 years, which will be assessed by the American Shoulder and Elbow Surgeons (ASES) shoulder score. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.

Connect with a study center

  • Fukui General Hospital

    Fukui, 910-3113
    Japan

    Site Not Available

  • Iwaki City Medical Center

    Fukushima, 973-8555
    Japan

    Site Not Available

  • Yuuai Medical Center

    Okinawa, 901-0224
    Japan

    Site Not Available

  • Kichijoji Minami Hospital

    Tokyo, 180-0003
    Japan

    Site Not Available

  • Kensington Private Hospital

    Whangarei, 0112
    New Zealand

    Site Not Available

  • Hoag Orthopedic Institute

    Irvine, California 92618
    United States

    Active - Recruiting

  • Panorama Orthopaedic and Spine Center

    Golden, Colorado 80401
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Active - Recruiting

  • Norton Healthcare, Inc

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • TRIA Orthopaedic Center Research Institute

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Mississippi Sports Medicine and Orthopaedic Center, PLLC

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Advance Bone and Joint

    Saint Peters, Missouri 63376
    United States

    Site Not Available

  • University of Buffalo

    Buffalo, New York 14215
    United States

    Site Not Available

  • Rothman Institute

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

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