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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	299318
Protocol serial number	CPMS 50609, IRAS 299318
Sponsor	Wrightington, Wigan and Leigh NHS Foundation Trust
Funder	LimaCorporate spa

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Mr Mike Walton
Scientific

Wrightington Hospital
Hall Lane
Appley Bridge
Wrightington
WN6 9EP
United Kingdom

Phone	+44 (0)1257 828212
Email	michael.walton@wwl.nhs.uk

Dr Lindsay Cunningham
Scientific

Ashton Research Hub
Queens Road
Ashton-in-Makerfield
WN4 8LB
United Kingdom

ORCID ID	0000-0002-1555-2022
Phone	+44 (0)1257 567204
Email	Lindsay.J.Cunningham@wwl.nhs.uk

Study information

Primary study design	Interventional
Study design	Non-randomized; Interventional; Design type: Treatment, Imaging, Surgery
Secondary study design	Non randomised study
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	28/02/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key 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
Key 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)
Date of first enrolment	14/06/2022
Date of final enrolment	14/06/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Wrightington Hospital

Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.