Zimmer TM Reverse Shoulder System PMCF Study v.1
Research type
Research Study
Full title
Prospective Post Market Clinical Follow-Up Study of the Zimmer Trabecular Metal Reverse Shoulder System
IRAS ID
103729
Contact name
Makaram Srinivasan
Contact email
Sponsor organisation
Zimmer GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 1 months, 30 days
Research 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. 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 SF-12 as well as AEs and radiographic parameters by analysis of x-rays.
REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/1462
Date of REC Opinion
15 Jan 2015
REC opinion
Further Information Favourable Opinion