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Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.
Details
| Lead sponsor | University of Southern Denmark |
|---|---|
| Phase | Phase 1 |
| Status | ENROLLING_BY_INVITATION |
| Enrolment | 30 |
| Start date | 2024-09-03 |
| Completion | 2026-09 |
Conditions
- Rotator Cuff Tears
- Rotator Cuff Injuries
- Rotator Cuff Tear Arthropathy
Interventions
- Stem-cell treatment
- Standard care
Primary outcomes
- Patient reported outcome of Oxford shoulder score — From inclusion and until 12 months after operation
A difference in 8 points from the oxford shoulder score questionnaire. The Oxford Shoulder Score comprises twelve items: four assessing the degree of pain and eight evaluating function. Each item is rated on a 5-point Likert scale, where 0 indicates the worst outcome, and 4 indicates the best. The scores from these 12 items are summed to produce a total score ranging from 0 to 48
Countries
Denmark