RECRUITING

Zimmer Biomet Shoulder Arthroplasty PMCF

Conditions

Shoulder Fractures Shoulder Arthritis Shoulder Osteoarthritis Shoulder Deformity Shoulder Injuries Shoulder Pain Total Shoulder Arthroplasty Glenoid Humeral Stem Stem Adapter Humeral Head Humeral Bearing Humeral Trays Head Adapter Reverse Anatomic Hemi

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-07-28

Study Completion:2033-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04984291

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.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Jeff Schram, MS

CONTACT

574-371-9786

jeffrey.schram@zimmerbiomet.com

Ryan Boylan, MBA

CONTACT

ryan.boylan@zimmerbiomet.com

Principal Investigator

Ryan Boylan

STUDY_DIRECTOR

Zimmer Biomet

Study Locations (Sites)

Hoag Orthopedic Institute

Irvine, California, 92618

United States

Panorama Orthopaedic and Spine Center

Golden, Colorado, 80401

United States

Northwestern University

Chicago, Illinois, 60208

United States

Norton Healthcare, Inc

Louisville, Kentucky, 40202

United States

William Beaumont Hospital

Royal Oak, Michigan, 48073

United States

TRIA Orthopaedic Center Research Institute

Bloomington, Minnesota, 55431

United States

Mississippi Sports Medicine and Orthopaedic Center, PLLC

Jackson, Mississippi, 39202

United States

Washington University

Saint Louis, Missouri, 63130

United States

Advance Bone and Joint

Saint Peters, Missouri, 63376

United States

University of Buffalo

Buffalo, New York, 14215

United States

Rothman Institute

Philadelphia, Pennsylvania, 19107

United States

Intermountain Health

Murray, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Ryan Boylan, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-28

Study Completion Date2033-08-15

Study Record Updates

Study Start Date2021-07-28

Study Completion Date2033-08-15

Terms related to this study

Keywords Provided by Researchers

Total Shoulder Arthroplasty
Glenoid
Humeral Stem
Stem Adapter
Humeral Head
Humeral Bearing
Humeral Trays
Head Adapter
Reverse
Anatomic
Hemi

Additional Relevant MeSH Terms

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