Clinical trial NCT05447819: Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
Official title: Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
Collaborators: name: DePuy Synthes
First posted: 2022-07-07
Enrollment: 122
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Based on the sample calculation the investigators intend to include a total number of 122 patients of which the first 56 patients will be studied using MB-RSA and DXA. The patients are allocated into two groups of equal of size:

1. DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group)
2. Standard DELTA Xtend Reverse Shoulder System (control group).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiostereometric analysis (RSA) [ Time Frame: Change from 1 week postoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: At 1 week and at 3 months, 6 months, 1 year and 2 years
measure: Western Ontario Osteoarthritis of the Shoulder index (WOOS) [ Time Frame: Change in WOOS score from preoperatively to 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: preoperatively and at at 3 months, 6 months, 1 year and 2 years
Secondary outcomes:
measure: Plain radiographs [ Time Frame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively ]
timeFrame: Preoperatively and at 1 week, 3 months and at 1 and 2 years postoperatively
measure: Duel energy x-ray absorptiometry (DXA) [ Time Frame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: Preoperatively and at 1 week, 3 months, 6 months, and at 1 and 2 years postoperatively
measure: Constant-Murley score [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
measure: Oxford Shoulder Score (OSS) [ Time Frame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: Preoperatively and 3 months, 6 months, and at 1 and 2 years postoperatively
measure: Side effects and complications [ Time Frame: 2 years postoperatively ]
timeFrame: 2 years postoperatively
measure: Pain and patient-satisfaction: visual analogue scale (VAS) [ Time Frame: 3 months, 6 months, and at 1 and 2 years postoperatively ]
timeFrame: 3 months, 6 months, and at 1 and 2 years postoperatively
measure: Cost-utility analysis [ Time Frame: 2 years postoperatively ]
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Herlev and Gentofte Hospital
Study officials:
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