Level A· Stronger Clinical EvidenceRandomized Controlled Trial

Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue Is Safe and Effectively Improves Short-term Clinical and Functional Results: A Prospective Randomized Controlled Trial Wit

Randelli PS., Cucchi D., Fossati C., Boerci L., Nocerino E., Ambrogi F.

Randomized Controlled Trial with a reported sample of 177 on Tendon Injury, Rotator Cuff, published in Am J Sports Med (2022) — summary generated from the PubMed abstract.

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Study type
Randomized Controlled Trial
Journal
Am J Sports Med (2022)
Country
United States
Reported sample size
177
PMID
35302901
DOI
10.1177/03635465221083324
NCT
NCT02783352

Abstract (original English)

Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of nonexpanded adipose-derived mesenchymal stem cells. Autologous microfragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of rerupture and represent an ideal target for nonexpanded mesenchymal stem cells. To evaluate the safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair. Randomized controlled trial; Level of evidence, 2. Consecutive patients referring to the investigation center for surgical treatment of magnetic resonance imaging-confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility. Those who were included were randomized to receive a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group) or not (control group). Clinical follow-up was conducted at 3, 6, 12, 18, and 24 months; at 18 months after surgery, magnetic resonance imaging of the operated shoulder was obtained to assess tendon integrity and rerupture rate. An overall 177 patients were screened, and 44 (22 per group) completed the 24-month follow-up. A statistically significant difference in fa

What this study does not prove

  • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

How we grade evidence
ArthroscopyFollow-Up StudiesHumansMagnetic Resonance ImagingProspective StudiesRotator CuffRotator Cuff InjuriesTreatment Outcome

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