Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System

Herlev and Gentofte Hospital

Status: Enrolling

Conditions: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear

Treatments: Procedure: Reverse shoulder arthroplsaty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05447819

H-21042181

Details and patient eligibility

About

This is a randomized controlled trial comparing the DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the standard DELTA Xtend Reverse Shoulder System (control group). All Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear indicating a reverse total shoulder arthroplasty referred to the orthopedic department at Herlev and Gentofte Hospital, Copenhagen University Hospital will be considered for participation in the trial. The following exclude from participation in the study: Below 50 years of age; Cognitive or linguistic impairment; insufficient glenoid bone stock; previous fracture in the upper extremities; autoimmune mediated inflammatory arthritis.A total of 122 patients will be included of which 56 will be part of the roentgen radiostereometric analysis. This will allow a maximum of 20% drop out. The primary outcome is magnitude and pattern of migration of the glenoid component and functional outcome by Western Ontario Osteoarthritis of the Shoulder Index (WOOS score). The secondary outcomes are position of arthroplasty, loosening, inferior scapular notching, patient-reported outcomes, functional outcome, readmission, complications, revisions, changes in bone mineral density of the proximal humerus assessed by duel energy x-ray absorptiometry and economy (cost utility analysis). The patients are examined before the operation and 1 week and 3, 6, 12 and 24 months after the operation.

Enrollment: 122 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Rotator cuff arthropathy defined as degeneration of the glenohumeral joint and wear or tear of at least one rotator cuff tendon
2. Degeneration of the glenohumeral joint with intact rotator cuff function but severe posterior wear of the glenoid (>20 degrees posterior wear)
3. Insufficient effect of non-surgical treatment with symptoms severe enough to justify shoulder arthroplasty.
4. ASA (American Society of Anesthesiology) score 1-3, physically fit for surgery and rehabilitation

Exclusion criteria

1. Below 50 years of age
2. Cognitive or linguistic impairment
3. Insufficient glenoid bone-stock
4. Previous fracture in the upper extremities
5. Patients with autoimmune mediated inflammatory arthritis
6. Glenoid border medial to the medial border of the coracoid on a true AP radiograph

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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122 participants in 2 patient groups

DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension

Experimental group

Description:

By using a lateralized glensphere complications can be reduced and patients can achieve an improved outcome. Currently, little is known about the results of the lateralized design. The initial results have been promising, but migration and eventually loosening of the prosthesis can lead to poor results and, in some cases, revision

Treatment:

Procedure: Reverse shoulder arthroplsaty

Standard DELTA Xtend Reverse Shoulder System

Active Comparator group

Description:

A design with a standard glenosphere is currently regarded as the standard treatment

Treatment:

Procedure: Reverse shoulder arthroplsaty