Comparing two types of reverse shoulder arthroplasty systems for rotator cuff issues
Official title: Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
Run by Herlev and Gentofte Hospital · NCT05447819 · Data updated 2026-11-12
This study is testing two different types of shoulder replacement systems to see which one helps people with severe shoulder problems feel and move better after surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup, Denmark) |
| Status | Recruiting |
| Started | August 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | October 2, 2024 |
| Trial ID | NCT05447819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Danish citizens over 50 years old with rotator cuff arthropathy or severe degeneration of the glenohumeral joint.
✕Probably not a fit
Patients under 50 years old, those with cognitive impairments, or those with insufficient glenoid bone stock will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a randomized controlled trial that compares the DELTA Xtend Reverse Shoulder System Lateralized Glenosphere Line Extension with the standard DELTA Xtend Reverse Shoulder System. It aims to evaluate the migration and functional outcomes in patients suffering from rotator cuff arthropathy or severe degeneration of the glenohumeral joint. The study will include Danish citizens referred to the orthopedic department at Herlev and Gentofte Hospital, with a total of 122 patients expected to participate. The primary outcome will focus on the magnitude and pattern of glenoid migration post-surgery.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and functional recovery for patients undergoing shoulder arthroplasty.
How similar studies have gone: Other studies have shown promising results with reverse shoulder arthroplasty approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Herlev and Gentofte Hospital
Hellerup, Denmark, Denmark Recruiting
Study contacts
- Study coordinator: Marie Louise Jensen, MD
- Email: marie.louise.jensen.02@regionh.dk
- Phone: +4525717963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.