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

NCT01480440 | Active Not Recruiting FDA Device

• 1 other identifier: CMU2010-28E
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 5

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.

Conditions

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

Keywords

Reverse Total Shoulder Arthroplasty (TSA); Reverse TSA; Osteoarthritis; Rheumatoid Arthritis; Post-traumatic arthritis; Ununited humeral head fracture; Irreducible 3-and 4-part proximal humeral fractures; Avascular necrosis; Gross rotator cuff deficiency; Failed total shoulder arthroplasty; Revision total shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• Survivorship

  Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

  10 Years

Secondary Outcomes (1)

• Pain and Functional Performance

  10 Years

Study Arms (1)

Trabecular Metal Reverse Shoulder System

Patients requiring primary or revision reverse total shoulder arthroplasty who receive the Trabecular Metal Reverse Shoulder System

Device: Trabecular Metal Reverse Shoulder System

Interventions

Trabecular Metal Reverse Shoulder System DEVICE

Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty

Also known as: TM Reverse Shoulder System, TM Reverse System, TM Reverse

Trabecular Metal Reverse Shoulder System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Each investigator will screen from his/her patients who suffer from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreduciable 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff dificiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision) who meet the inclusion/exclusion criteria stated in the protocol

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Norton Orthopaedic & Sports Medicine

Louisville, Kentucky, 40241, United States

Location

The Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Royal Blackburn Hospital

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: January 1, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (4); GB (1)