Zimmer Biomet Shoulder Arthroplasty PMCF
Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Zimmer Biomet
584 participants
Jul 28, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria14
- 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 Criteria15
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
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
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04984291