SMR STEMLESS
Research type
Research Study
Full title
A multicentre, prospective clinical study analysing outcomes of shoulder arthroplasty with SMR STEMLESS
IRAS ID
193744
Contact name
Stephen Cook
Contact email
Sponsor organisation
Limacorporate Spa
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 1 days
Research summary
Summary of Research
The SMR STEMLESS clinical study is a research project following patients treated with a novel design of shoulder replacement. It will include patients suffering from severe joint diseases of the shoulder and who require shoulder replacement surgery. Shoulder replacement surgery is aimed at relieving pain and restoring shoulder function. Current shoulder replacements frequently involve insertion of a “stem” into the upper arm bone (humerus). This can lead to complications thought to be due to the “stem”. (may wish to include some brief complications here). The stem-less replacement (SMR STEMLESS) has been designed with the aim of reducing these complications.
The objective of this study is therefore to explore how well people recover after shoulder replacement with this novel stemless shoulder replacement. This will be assessed over 5 years in three different countries in Europe using patient completed questionnaires and clinical and X-ray assessments.Summary of Results
Study title The study looked at a shoulder implant to see if it helps people with shoulder problems feel better.
Who carried out the research? The implant was made by a company called Limacorporate S.p.A., which makes prosthesis for bones and joints. The research was carried out by four hospitals in Europe.
Where and when the study took place? Doctors from hospitals in the Netherlands, the United Kingdom, and Germany worked together on this study. It started in March 2016 and ended in November 2024.
Why was the study on the shoulder prosthesis needed? The company who made the shoulder prosthesis wanted to know if it was good for people with shoulder problems.
Main questions studied: The doctors wanted to see if the shoulder prosthesis helped people feel better and if it kept working well as time passed.
Who took part in this study? 78 patients with shoulder problems took part. They were chosen by doctors using specific medical rules.
What happened during the study? Each person had surgery to get the shoulder implant. After surgery, doctors checked how they were doing for up to five years. They wanted to see if the implant helped reduce pain and improve movement.
What were the results of the study?The results were good. Most people felt better, had less pain, and their shoulders worked well over time.REC name
West of Scotland REC 1
REC reference
16/WS/0078
Date of REC Opinion
17 May 2016
REC opinion
Further Information Favourable Opinion