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โ† Trials
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Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue

Recruitingn/aAges 18 Years - anyAllUniversity of Milan
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In plain words

What the trial is, and whether it could suit you

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 rotator cuff repair. The primary goal of this study was to test the following hypothesis: an intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology could improve the clinical outcomes of single-row arthroscopic rotator cuff repair in terms of points in the Constant-Murley score (CMS) collected at least 5 years after surgery. Background and Significance: Rotator cuff surgery was initially proposed at the end of the 19th century and evolved then from open to arthroscopic techniques, rising quickly from a minor niche to a fully recognized subspecialty. To improve clinical and functional results and reduce the retear rate, new fixation

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • magnetic resonance imaging (MRI)
  • VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
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Where

1 site
ASST Gaetano Pini-CTO
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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