Who is eligible for clinical trial NCT01480440?

Participants must meet the protocol's inclusion criteria for Osteoarthritis. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT01480440 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-22

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System (NCT01480440)

Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System Used in Primary or Revision Reverse Total Shoulder Arthroplasty

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Zimmer Biomet

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).

Location: University of California, San Francisco — San Francisco, California

Age range: 18 Years

🧪 Interventions in This Study

Trabecular Metal Reverse Shoulder System (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗