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

RecruitingNAAges 50 Years - anyAllHerlev and Gentofte Hospital
NCT05447819 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Reverse shoulder arthroplsaty
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Where

1 site
Herlev and Gentofte Hospital
Hellerup, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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