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

Rheumatoid Arthritis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01480440
• Study type: Observational
• Source: Zimmer Biomet
• Status: Active, not recruiting
• Start date: January 2011
• Completion date: December 2026