2023 ISAKOS Biennial Congress Paper
Arthroscopic Rotator Cuff Repair Augmentation With Autologous Micro-Fragmented Lipoaspirate Tissue is Safe And Effectively Improves Short-Term Clinical and Functional Results. A Prospective Randomized Controlled Trial With 24-Month Follow-Up
Pietro S. Randelli, MD, Prof., Milan ITALY
Davide Cucchi, MD, Bonn, Deutschland GERMANY
Chiara Fossati, MD, Milano ITALY
Linda Boerci, MD, Milano ITALY
Elisabetta Nocerino, MD, Cernusco Sul Naviglio, Milano ITALY
Federico Ambrogi, PhD, Milano ITALY
Alessandra Menon, MD, Milano, Milano ITALY
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO & IRCCS Policlinico San Donato, Milano, ITALY
FDA Status Cleared
Summary
The intra-operative injection of autologous micro-fragmented adipose tissue is safe and effective in improving short-term clinical and functional results after arthroscopic rotator cuff repair
Abstract
Purpose
Autologous micro-fragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of non-expanded adipose-derived mesenchymal stem cells. Autologous micro-fragmented lipoaspirate tissue is expected to create a suitable microenvironment for tendon repair and regeneration. Rotator cuff tears show a high incidence of re-rupture and represent an ideal target for non-expanded mesenchymal stem cells. The aim of study was to evaluate safety and efficacy of autologous lipoaspirate tissue in arthroscopic rotator cuff repair.
Methods
Consecutive patients referring to the investigation center for surgical treatment of MRI-confirmed degenerative posterosuperior rotator cuff tears were assessed for eligibility and randomized to receive a single-row arthroscopic rotator cuff repair either followed by intra-operative injection of autologous micro-fragmented 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; 18 months after surgery, MRI of the operated shoulder was obtained to assess tendon integrity and re-rupture rate.
Results
One hundred and seventy-seven patients were screened and 44 (22 per group) completed the 24-month follow-up period. A statistically significant difference in favour of the treatment group in terms of Constant-Murley score emerged at the primary endpoint at 6-month follow-up (control group: 76.66 ± 10.77 points; treatment group: 82.78 ± 7.00 points; p=0.0050). No significant differences in clinical outcome measures were encountered at any of the other follow-up points. No significant differences in terms of re-rupture rate, complication rate, and number of adverse events emerged between the two groups.
Conclusion
This prospective, randomized, controlled trial demonstrated that the intra-operative injection of autologous micro-fragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair. Although still in the early stages of application, augmentation of rotator cuff repair with autologous micro-fragmented adipose tissue appears a suitable strategy to enhance tendon repair and regeneration. These results open new perspectives in the enhancement of rotator cuff repair, paving the way to a possibly accelerated return to pre-injury level of performance in the patients treated with autologous micro-fragmented adipose tissue, which could have a particularly relevant role in sports medicine.