Status:
ACTIVE_NOT_RECRUITING
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
Detailed Description
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be ...
Eligibility Criteria
Inclusion
- Patient is \> 18 years of age;
- Patient is skeletally mature;
- Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
- Patient is willing and able to provide written informed consent;
- Patient is willing and able to cooperate in the required post-operative therapy;
- Patient is willing and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed the Institutional Review Board (IRB)/Ethical Review Board (ERB) approved informed consent.
Exclusion
- The patient is a prisoner;
- The patient is mentally incompetent or unable to understand what participation in the study entails;
- The patient is a known alcohol or drug abuser;
- The patient is anticipated to be non-compliant;
- The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
- The patient has a local/systemic infection;
- The patient is known to be pregnant;
- The patient has marked bone loss;
- The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
- The patient is unwilling or unable to give consent or to comply with the follow-up program.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01480440
Start Date
January 1 2011
End Date
December 1 2026
Last Update
October 29 2025
Active Locations (5)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, United States, 40241
3
The Rothman Institute
Egg Harbor, New Jersey, United States, 08234
4
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107