Using fat tissue to improve rotator cuff repair outcomes
Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trialin Question Won by Our Research Group.
This study is testing if using fat tissue from patients can help improve recovery and results for people having surgery for full-thickness rotator cuff tears.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06960343 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in enhancing the outcomes of arthroscopic rotator cuff repair. It focuses on patients with full-thickness supraspinatus and infraspinatus tendon tears who are undergoing surgery. The study will assess clinical outcomes using the Constant-Murley score at least five years post-surgery, comparing results between those receiving the fat tissue injection and those who do not. Various assessments, including MRI and strength measurements, will be utilized to gather comprehensive data on recovery and function.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with full-thickness supraspinatus and infraspinatus tendon tears requiring arthroscopic repair.
Not a fit: Patients with partial or massive rotator cuff tears, significant muscle atrophy, or other shoulder instabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved healing and reduced retear rates in rotator cuff repairs.
How similar studies have performed: While the use of autologous fat tissue in surgical procedures is gaining interest, this specific approach in rotator cuff repair is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Milan, Italy
- ASST Gaetano Pini-CTO — Milan, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandra Menon, PhD
- Email: ale.menon@me.com
- Phone: +393498694424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.