Ireland
--:--IST
Recruiting Not applicable

Zimmer Biomet Shoulder Arthroplasty PMCF

NCT04984291 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2021-07-28
Last updated
2026-04-28

Condition(s) studied

Shoulder FracturesShoulder ArthritisShoulder OsteoarthritisShoulder DeformityShoulder InjuriesShoulder Pain

Investigational drug(s) / intervention(s)

Alliance GlenoidIdentity Stem

Alliance Glenoid: Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty

Identity Stem: Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty

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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Implant Survivorship at 10 years follow-up (Kaplan Meier) — 10 years
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
  • Frequency and Incidence of Adverse Events (Safety) — 10 years
    Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.

Trial sites (17)

FacilityCityRegionStatus
Hoag Orthopedic Institute Irvine California Active Not Recruiting
Panorama Orthopaedic and Spine Center Golden Colorado Recruiting
Northwestern University Chicago Illinois Active Not Recruiting
Norton Healthcare, Inc Louisville Kentucky Terminated
William Beaumont Hospital Royal Oak Michigan Active Not Recruiting
TRIA Orthopaedic Center Research Institute Bloomington Minnesota Active Not Recruiting
Mississippi Sports Medicine and Orthopaedic Center, PLLC Jackson Mississippi Active Not Recruiting
Advance Bone and Joint City of Saint Peters Missouri Active Not Recruiting
Washington University St Louis Missouri Active Not Recruiting
University of Buffalo Buffalo New York Active Not Recruiting
Rothman Institute Philadelphia Pennsylvania Active Not Recruiting
Intermountain Health Murray Utah Recruiting
Fukui General Hospital Fukui Japan Active Not Recruiting
Iwaki City Medical Center Fukushima Japan Active Not Recruiting
Yuuai Medical Center Okinawa Japan Active Not Recruiting
Kichijoji Minami Hospital Tokyo Japan Withdrawn
Kensington Private Hospital Whangarei New Zealand Withdrawn
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04984291 on ClinicalTrials.gov ↗ ← All trials in Japan