Early stability and clinical outcomes of the LIMA Stemless Reverse Shoulder Replacement assessed using x-ray analysis, clinical follow-up and patient-reported outcomes
| ISRCTN | ISRCTN79485429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79485429 |
| IRAS number | 299318 |
| Secondary identifying numbers | CPMS 50609, IRAS 299318 |
- Submission date
- 13/09/2022
- Registration date
- 21/09/2022
- Last edited
- 08/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
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). The stability of this component will be evaluated using radiostereometric analysis (RSA), a special x-ray technique which allows observation and measurement of very small movements (migrations) over a 2-year postoperative period.
Who can participate?
Patients over the age of 55 years with concentric glenohumeral (shoulder) osteoarthritis
What does the study involve?
All participants will have surgery with a LIMA reverse glenoid and the stemless humeral component which are part of the Shoulder Modular System (LIMA Corporate, Italy). At the time of listing for surgery, if the surgeon considers the use of this type of shoulder replacement clinically appropriate, the patient will be invited to participate in this study. If the patient is willing to consider participation, a participation information sheet will be provided and the patient is given the opportunity to discuss this and ask questions with the research staff. During the clinical visit, pre-operative information, including clinical and patient-reported data, will be collected as part of routine care. Written consent to participate in the study will then be sought in person at either a follow-up clinic visit or at a pre-op assessment. Final confirmation of willingness to participate in the RSA study will be affirmed by the surgeon on the ward during the booking in process. The research team will be available to address any further questions and complete any study documentation. Plain x-ray and CT scanning are routinely used preoperatively in patients being assessed for shoulder arthroplasty. The first postoperative RSA image will be obtained within 1 week of implantation (usually while the patient is still an in-patient) and the patient will be followed up with RSA images and data collection at 3 months, 6 months, 12 months and 2 years.
What are the possible benefits and risks of participating?
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 include preservation of host bone stock and prevention of stress shielding.
Where is the study run from?
Wrightington, Wigan & Leigh Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
August 2021 to February 2025
Who is funding the study?
LimaCorporate (Italy)
Who is the main contact?
Lindsay Cunningham, Lindsay.J.Cunningham@wwl.nhs.uk
Contact information
Scientific
Wrightington Hospital
Hall Lane
Appley Bridge
Wrightington
WN6 9EP
United Kingdom
| Phone | +44 (0)1257 828212 |
|---|---|
| michael.walton@wwl.nhs.uk |
Scientific
Ashton Research Hub
Queens Road
Ashton-in-Makerfield
WN4 8LB
United Kingdom
 ORCID ID |
0000-0002-1555-2022 |
|---|---|
| Phone | +44 (0)1257 567204 |
| Lindsay.J.Cunningham@wwl.nhs.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Treatment, Imaging, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A study of the performance of the novel LIMA stemless reverse humeral replacement; a prospective radio-stereometric analysis study of the magnitude and pattern of migration of humeral components |
| Study hypothesis | In patients over the age of 60, with painful rotator cuff arthropathy of the glenohumeral joint, the LIMA stemless humeral component has acceptable short-term stability. |
| Ethics approval(s) | Approved 17/12/2021, West Midlands - Solihull Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, UK; +44 (0)207 104 8191, +44 (0)207 104 8269; solihull.rec@hra.nhs.uk), ref: 21/WM/0227 |
| Condition | Concentric glenohumeral osteoarthritis |
| Intervention | Participants will be invited to participate at the time of listing for surgery and pre-operative information, including clinical and patient-reported data, will be obtained after fully informed consent is given. Plain x-ray and CT scanning are routinely used preoperatively in patients being assessed for shoulder arthroplasty. The first postoperative RSA image will be obtained within 1 week of implantation and the patient will be followed up with RSA images and data collection at 3 months, 6 months, 12 months and 2 years. |
| Intervention type | Other |
| Primary outcome measure | The magnitude and pattern of migration of the LIMA hybrid anatomic glenoid component measured using model-based RSA over a minimum period of 2 years |
| Secondary outcome measures | 1. Clinical and patient-reported outcomes collected using the Shoulder Pain and Disability Index (SPADI) questionnaire from pre-op to 2 years 2. Adverse events, implant survival and need for surgical revision”, collected by the direct care team at clinical visits and by the research team at follow-up visits if this does not coincide with a clinical visit, monitored over a minimum of 2 years |
| Overall study start date | 12/08/2021 |
| Overall study end date | 28/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Participant inclusion criteria | 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 rotator cuff Previous inclusion criteria: 1. Male and female patients over the age of 55 years 2. Concentric glenohumeral osteoarthritis 3. Glenoid suitable for non-augmented anatomical component (Walch A or B1) 4. Intact rotator cuff |
| Participant exclusion criteria | 1. Inability to consent 2. Inflammatory arthropathy 3. Sequelae of trauma 4. Patients who are unable to attend follow-up for imaging and required assessment (due to the need to access specialist equipment at Wrightington for the RSA imaging) |
| Recruitment start date | 14/06/2022 |
| Recruitment end date | 14/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Appley Bridge
Wigan
WN6 9EP
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Helen Spickett
Research and Development Unit
Wrightington Hospital
Hall Lane
Appley Bridge
Wrightington
WN6 9EP
England
United Kingdom
| Phone | +44 (0)1257567204 |
|---|---|
| Linzi.heaton@wwl.nhs.uk | |
| Website | http://www.wwl.nhs.uk/ |
"ROR" |
https://ror.org/028mrxf52 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The information gathered in the study will be published and peer-reviewed in scientific research journals and discussed at scientific conferences. Preliminary results will be available after 2 years and final results are expected within 4 years. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/12/2022: The sponsor email was updated.
19/10/2022: The inclusion criteria were updated.
13/09/2022: Trial's existence confirmed by the NIHR.
