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Active, not recruiting Observational

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

NCT01480440 · tracked via the Priya Life Science UK tracker
Phase
Observational
Started
2011-01
Last updated
2026-04-28

Condition(s) studied

OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisUnunited Humeral Head FractureIrreducible 3-and 4-part Proximal Humeral FracturesAvascular NecrosisGross Rotator Cuff DeficiencyRevision Total Shoulder Arthroplasty

Investigational drug(s) / intervention(s)

Trabecular Metal Reverse Shoulder System

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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.

Primary outcome measure(s)

  • Survivorship — 10 Years
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Trial sites (5)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01480440 on ClinicalTrials.gov ↗ ← All trials in the UK