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

A study of the performance of the novel LIMA hybrid anatomic replacement; a prospective radio-stereometric analysis study of the magnitude and pattern of migration of the glenoid and humeral components

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99257265

Enrollment

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

Having obtained ethical approval, 20 patients will be invited to participate at the time of listing for surgery. Pre-operative information, including clinical and PROM data, will be obtained after ful

primarily to investigate the accuracy of the SmartSpace planning software by measuring the post-operative component position. The CT scan will also be used to observe and comment on the status of bony

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 and required assessment

Design outcomes

Primary

Measure	Time frame
The magnitude and pattern of migration (how far in which direction) of the LIMA Hybrid Anatomic glenoid component, measured using radiostereometric analysis (RSA) involving special x-ray imaging and model-based RSA computer analysis. Imaging takes place over a period of 2 years; immediately post-op, and at 3, 6, 12 & 24 months post-op.	—

Secondary

Measure	Time frame
1. Clinical and patient-reported outcomes collected using the Shoulder Pain and Disability Index (SPADI) questionnaire from pre-op to 2 years 2. The accuracy of SmartSpace software (used for pre-operative planning) monitored by checking implant positioning by means of metal artefact reduction (MARS) CT scans at 3 months 3. 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	—

Measure

Time frame

1. Clinical and patient-reported outcomes collected using the Shoulder Pain and Disability Index (SPADI) questionnaire from pre-op to 2 years 2. The accuracy of SmartSpace software (used for pre-operative planning) monitored by checking implant positioning by means of metal artefact reduction (MARS) CT scans at 3 months 3. 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