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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN79485429
Enrollment
20
Registered
2022-09-21
Start date
2022-06-14
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concentric glenohumeral osteoarthritis Musculoskeletal Diseases

Interventions

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 consen

Sponsors

Wrightington, Wigan and Leigh NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026