Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

Running, not enrolling

Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3-and 4-part Proximal Humeral Fractures, Avascular Necrosis, Gross Rotator Cuff Deficiency, Revision Total Shoulder Arthroplasty

In brief

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.

Key facts

Study ID

NCT01480440

Run by

Zimmer Biomet

People needed

200

Starts

2011-01-01

Expected to finish

2026-12-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Norton Orthopaedic & Sports Medicine — Louisville, Kentucky, United States
• The Rothman Institute — Egg Harbor, New Jersey, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States
• Royal Blackburn Hospital — Blackburn, Lancashire, United Kingdom

Full record on ClinicalTrials.gov

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