Performance of the novel LIMA Stemless Reverse Humeral Replacement V1
Research type
Research Study
Full title
A Study of the Performance of the Novel LIMA Stemless Reverse Humeral Replacement; A Prospective Radio-Stereometric Analysis (RSA) Study of the Magnitude and Pattern of Migration of humeral components.
IRAS ID
299318
Contact name
Michael Walton
Contact email
Sponsor organisation
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This study will be the first known study to investigate the stability and outcomes of the LIMA stemless humeral component in Total Reverse Shoulder Arthroplasty (one of the replacement parts for the bony ball and socket joint of the shoulder). We propose to evaluate the stability of this component by the use of radiostereometric analysis (RSA); a special x-ray technique which allows observation and measurement of very small movements (migrations) over a 2 year postoperative period.
Participants suitable for the study will be identified preoperatively in outpatient clinics as part of standard care. Informed consent will be taken following detailed explanations of the intervention shared within the Patient Information literature and discussions with the study team. Validated questionnaires will be completed before the operation to provide a measure of pain and functional ability. The range of movement of the shoulder will also be measured by a member of the research team.
The operation will be undertaken by a senior orthopaedic consultant. Following the operation, the clinical follow up care and physiotherapy will be the standard milestone driven pathway of rehabilitation for patients who have had a total shoulder replacement.
The RSA images and validated questionnaires assessing pain and function will continue to be collected at 3, 6, 12 and 24 months after the operation to assess changes over time. The range of movement of the shoulder will also be re-measured at these time-points to assess functional changes in the range of movement.
We will record any adverse events at every follow-up visit and these will be monitored until the event has either resolved or reaches a time until no further intervention is required.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
21/WM/0226
Date of REC Opinion
17 Dec 2021
REC opinion
Further Information Favourable Opinion