Zimmer Biomet Shoulder Arthroplasty PMCF

Description

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.

Conditions

Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity, Shoulder Injuries, Shoulder Pain

Study Overview

Study Details

Study overview

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.

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

Zimmer Biomet Shoulder Arthroplasty PMCF

Condition
Shoulder Fractures
Intervention / Treatment

-

Contacts and Locations

Irvine

Hoag Orthopedic Institute, Irvine, California, United States, 92618

Golden

Panorama Orthopaedic and Spine Center, Golden, Colorado, United States, 80401

Chicago

Northwestern University, Chicago, Illinois, United States, 60208

Louisville

Norton Healthcare, Inc, Louisville, Kentucky, United States, 40202

Royal Oak

William Beaumont Hospital, Royal Oak, Michigan, United States, 48073

Bloomington

TRIA Orthopaedic Center Research Institute, Bloomington, Minnesota, United States, 55431

Jackson

Mississippi Sports Medicine and Orthopaedic Center, PLLC, Jackson, Mississippi, United States, 39202

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63130

Saint Peters

Advance Bone and Joint, Saint Peters, Missouri, United States, 63376

Buffalo

University of Buffalo, Buffalo, New York, United States, 14215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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.

Ages Eligible for Study

20 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Ryan Boylan, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

2033-08-15