Status:
RECRUITING
Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue
Lead Sponsor:
University of Milan
Collaborating Sponsors:
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)
ASST Gaetano Pini-CTO
Conditions:
Arthroscopic Rotator Cuff Repair
Augmentation
Eligibility:
All Genders
18+ years
Brief Summary
Specific Aims : The aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification)
- Indication for arthroscopic rotator cuff repair
- Informed consent to participate in the study
- Informed consent to participate for the duration of the study
Exclusion
- Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification)
- Massive rotator cuff tear (C4 according to the SCOI classification)
- Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification)
- Associated anterior, posterior, or multidirectional shoulder instability
- Indication for repair of a SLAP lesion of the biceps anchor
- Grade III or IV muscle atrophy of the supraspinatus and infraspinatus tendons (according to Goutallier or Fuchs classification)
- Intra-articular hyaluronic acid or corticosteroid infiltration within 3 mo from the planned surgical procedure
- Medical comorbidities contraindicating arthroscopic shoulder surgery
- Local (shoulder, abdominal region, gluteal region) or systemic infection, osteomyelitis, or sepsis
- Diabetes mellitus, untreated thyroid disease, chronic kidney disease, rheumatoid arthritis
- Immunodeficiency
- Chronic disorders involving coagulation, platelet aggregation, or severe coagulopathy
- Severe cardiovascular disease
- Stroke or acute cardiovascular event within 6 mo from the planned surgical procedure
- Weight loss for any cause .30 kg in 12 mo or .10 kg in 12 mo without a cause
- Eating disorders or body dysmorphic disorder
- Varices, phlebitis, or scars next to the planned adipose tissue harvesting site
- Alcohol/drug addiction or psychiatric disease compromising compliance with postoperative protocols
- Pregnancy or breastfeeding women
- Informed consent not accepted
Key Trial Info
Start Date :
April 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 11 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06960343
Start Date
April 11 2025
End Date
April 11 2026
Last Update
May 7 2025
Active Locations (1)
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1
ASST Gaetano Pini-CTO
Milan, Italy, Italy, 20122