Using fat tissue to improve rotator cuff repair outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• ASST Gaetano Pini-CTO
  Milan, Italy, Italy Recruiting

Study contacts

• Study coordinator: Alessandra Menon, PhD
• Email: ale.menon@me.com
• Phone: +393498694424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.