NCT01480440

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System. Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System. Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.

Conditions

• 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

Interventions

Type	Name	Description
DEVICE	Trabecular Metal Reverse Shoulder System	Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty

Timeline

• Start date: 2011-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2011-11-28
• Last updated: 2025-10-29

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study