SMR Reverse HP Study [CAG Pilot]
Research type
Research Study
Full title
Clinical and Radiographic outcomes of reverse shoulder arthroplasty performed with 36-mm CoCrMo vs 40-mm cross-linked UHMWPE glenospheres at minimum 2-years follow-up.
IRAS ID
312178
Contact name
Ian Trail
Contact email
Sponsor organisation
LimaCorporate S.p.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This research study will take place at Wrightington Hospital and involves retrospective collection of data from the medical records of living or deceased patients who were treated with either the polyethylene glenosphere shoulder replacement compared to the cobalt chromium metal glenosphere shoulder replacement between 1st January 2013 and 1st January 2020.
Both of the devices are CE-marked and marketed in the UK and Europe. The purpose of the research is to gather data from assessments performed as per standard of care from pre-operation to approximately 2-years after the shoulder operation to determine the safety and effectiveness of the devices. A comparison of the safety and effectiveness of both devices will also be made. Data will be collected from 70 patients implanted with the polyethylene glenosphere shoulder replacement and 70 patients implanted with the cobalt chromium metal glenosphere shoulder replacement, ie 140 patients in total.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0098
Date of REC Opinion
13 Jul 2022
REC opinion
Further Information Favourable Opinion