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NCT04984291 | RECRUITING | Shoulder Fractures

Zimmer Biomet Shoulder Arthroplasty PMCF
Sponsor:

Zimmer Biomet

Brief 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.

Condition or disease

Shoulder Fractures

Shoulder Arthritis

Shoulder Osteoarthritis

Shoulder Deformity

Shoulder Injuries

Shoulder Pain

Intervention/treatment

Alliance Glenoid

Identity Stem

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 584 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Actual Study Start Date : 2021-07-28
Estimated Primary Completion Date : 2033-08-15
Estimated Study Completion Date : 2033-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient must be 20 years of age or older.
  • * Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
  • * Patient is a candidate for shoulder arthroplasty due to one or more of the following
    • * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
    • * Rheumatoid arthritis.
    • * Correction of functional deformity.
    • * Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
    • * Difficult clinical management problems, where other methods of treatment may not 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 Criteria
    • * Patient is unwilling or unable to give consent or to comply with the follow-up program.
    • * Patient has any condition which would in the judgement of the Investigator, place the 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 to understand 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 or unwilling to follow directions.
    • * Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
    • * Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
    • * Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
    • * Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
    • * 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.
Zimmer Biomet Shoulder Arthroplasty PMCF

Location Details

NCT04984291

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, California

Hoag Orthopedic Institute

Irvine, California, United States, 92618

RECRUITING

United States, Colorado

Panorama Orthopaedic and Spine Center

Golden, Colorado, United States, 80401

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60208

RECRUITING

United States, Kentucky

Norton Healthcare, Inc

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Michigan

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

ACTIVE NOT RECRUITING

United States, Minnesota

TRIA Orthopaedic Center Research Institute

Bloomington, Minnesota, United States, 55431

RECRUITING

United States, Mississippi

Mississippi Sports Medicine and Orthopaedic Center, PLLC

Jackson, Mississippi, United States, 39202

RECRUITING

United States, Missouri

Washington University

St. Louis, Missouri, United States, 63130

ACTIVE NOT RECRUITING

United States, Missouri

Advance Bone and Joint

Saint Peters, Missouri, United States, 63376

RECRUITING

United States, New York

University of Buffalo

Buffalo, New York, United States, 14215

RECRUITING

United States, Pennsylvania

Rothman Institute

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Utah

Intermountain Health

Murray, Utah, United States, 84107

ACTIVE NOT RECRUITING

Japan,

Fukui General Hospital

Fukui, Japan, 910-3113

ACTIVE NOT RECRUITING

Japan,

Iwaki City Medical Center

Fukushima, Japan, 973-8555

ACTIVE NOT RECRUITING

Japan,

Yuuai Medical Center

Okinawa, Japan, 901-0224

ACTIVE NOT RECRUITING

Japan,

Base girl south support pita l

Tokyo, Japan, 180-0003

RECRUITING

New Zealand,

Kensington Private Hospital

Whangarei, New Zealand, 0112