Zimmer Biomet Shoulder Arthroplasty PMCF

Zimmer Biomet

Status

Enrolling

Conditions

Shoulder Pain

Shoulder Osteoarthritis

Shoulder Injuries

Shoulder Deformity

Shoulder Arthritis

Shoulder Fractures

Treatments

Device: Identity Stem

Device: Alliance Glenoid

Study type

Interventional

Funder types

Industry

Identifiers

NCT04984291

CMU2019-35E

Details and patient eligibility

About

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.

Full 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.

Enrollment

584 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.