Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Mike Walton
+44 (0)1257 828212
michael.walton@wwl.nhs.uk


Dr Lindsay Cunningham
+44 (0)1257 567204
Lindsay.J.Cunningham@wwl.nhs.uk


Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Early stability and clinical outcomes of the LIMA Hybrid Shoulder Replacement assessed using x-ray analysis, clinical follow-up and patient-reported outcomes
Back

Early stability and clinical outcomes of the LIMA Hybrid Shoulder Replacement assessed using x-ray analysis, clinical follow-up and patient-reported outcomes

Not Recruiting

Open to: All Genders

Age: Adult

Wigan

Medical Conditions

Concentric glenohumeral osteoarthritis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study will be the first known study to investigate the stability and outcomes of the LIMA hybrid glenoid component and stemless humeral component in total anatomic shoulder arthroplasty (the replacement parts for the bony ball and socket joint of the shoulder). The stability of the components will be evaluated using radio stereometric analysis (RSA), a special x-ray technique which allows observation and measurement of very small movements (migrations) over a 2-year postoperative period.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

14 Jun 2022 14 Jun 2024

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 timepoints to assess functional changes in the range of movement. A CT scan will be done 3 months after the operation to check the position of the new Hybrid glenoid. The researchers 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.


Patients over the age of 55 with concentric glenohumeral (shoulder) osteoarthritis

You can take part if:


Current inclusion criteria as of 19/10/2022:
1. Male and female patients
2. Concentric glenohumeral osteoarthritis
3. Glenoid suitable for non-augmented anatomical component (Walch A or B1)
4. Intact ro


You may not be able to take part if:


1. Inability to consent2. Inflammatory arthropathy3. Sequelae of trauma4. Patients who are unable to attend follow-up and required assessment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Wrightington Hospital
    Hall Lane Appley Bridge
    Wigan
    WN6 9EP

Risks include some increase in radiation dose to the patient. Standard surgical risks apply. All implants to be used are approved for human use in the UK. Potential benefits to the patient may be found although the study will primarily benefit future users of the product. Patients in the study can be reassured that they are being followed up closely.

Mr Mike Walton
+44 (0)1257 828212
michael.walton@wwl.nhs.uk


Dr Lindsay Cunningham
+44 (0)1257 567204
Lindsay.J.Cunningham@wwl.nhs.uk



The study is sponsored by Wrightington, Wigan and Leigh NHS Foundation Trust and funded by LimaCorporate spa.




We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN99257265

Or CPMS 50648

Last updated 19 October 2022

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top