Status:
ENROLLING_BY_INVITATION
Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)
Lead Sponsor:
University of Southern Denmark
Conditions:
Rotator Cuff Tears
Rotator Cuff Injuries
Eligibility:
All Genders
40-69 years
Phase:
PHASE1
Brief Summary
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 th...
Detailed Description
Damage to the tendons that stabilize the shoulder, particularly the supraspinatus tendon tear, has been recognized as the key lesion in rotator cuff tears. However, the lack of full functional recover...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Clinical signs and symptoms compatible with a traumatic RCT
- MR verified supraspinatus tear
- Reparable lesion with tendon retraction \< 2 cm.
- Fatty infiltration level 0-2 (out of 5) according to Fuchs et al. and based on Goutalliers classification
- No history of inflammatory disease
- ASA score \< 3 (patients in good health)
- Signed consent to the study (including use of relevant data from the patient's electronic health records)
- Exclusion Criteria
- No MRI of the shoulder
- Former surgery in the affected shoulder
- Signs of infection
- Immunosuppression (due to clinical condition or medical therapy)
- History of inflammatory disease
- Malignancy within 5 years
- Previous radiotherapy to the shoulder
- BMI under 18
- BMI above 35
- Coagulopathy
- Non-Danish speaking patients
Exclusion
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06505135
Start Date
September 3 2024
End Date
September 1 2026
Last Update
October 2 2024
Active Locations (1)
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1
Orthopaedic Research Unit, Department of Orthopaedics, Hospital Sønderjylland, Region of Southern Denmark.
Sønderborg, Danmark, Denmark, 6400