Rotator cuff repair with autologous microfragmented adipose tissue may improve outcomes
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Published results showed intraoperative injection of autologous microfragmented adipose tissue may safely and effectively improve short-term clinical and functional outcomes after single-row arthroscopic rotator cuff repair.
“Although still in the early stages of application, augmentation of rotator cuff repair with autologous microfragmented adipose tissue appears a suitable strategy to enhance tendon repair and regeneration,” Pietro S. Randelli, MD, told Healio.
Randelli and colleagues randomly assigned patients with degenerative posterosuperior rotator cuff tears to receive either a single-row arthroscopic rotator cuff repair alone (control group) or with intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology (treatment group). Researchers performed clinical follow-up at 3, 6, 12, 18 and 24 months, and obtained MRI of the operated shoulder at 18 months after surgery to assess tendon integrity and re-rupture rate.
Among the 177 patients screened for inclusion, researchers enrolled 52 patients, of whom 44 completed the 24-month follow-up. Results showed statistically significant differences in the Constant-Murley score at the primary endpoint of 6-months follow-up in favor of the treatment group. Researchers found no significant differences in clinical outcome measures at any of the other follow-up points. Researchers also noted no significant differences in re-rupture rate, complication rate and number of adverse events between the two groups.
“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 microfragmented adipose tissue, which could have a particularly relevant role in sports medicine,” Randelli said.
Perspective
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This research is well done but gives us a frustrating window into the world of biologic augmentation. It is a randomized-controlled trial comparing single-row rotator cuff repair with microfragmented adipose tissue (Lipogems Device) vs. no augmentation with known excellent surgeons and authors. They chose a difference between groups with the Constant-Murley score of seven points as a clinically significant difference. The Constant-Murley score is a 100-point score. The mean normal Constant-Murley score for age group 51 to 60 years is 90. A study by Sheng Xu, MBBS, MRCS, and colleagues powered on a seven-point change in score found the minimal clinical important difference for the Constant-Murley score was 6.3. Pietro S. Randelli, MD, and colleagues found this at 6 months but no difference at 12 months. This was really the only difference that they found. The re-rupture rate and radiological quality of the repair determined by MRI at 6 months was not different.
This type of randomized study is extremely difficult to perform, and the authors’ tremendous work ethic and study design eliminated much of the bias, which may have influenced the study to a more positive way. Biologic augmentation to aid the healing of rotator cuff repairs will always be mired by variability. Using autologous cells that need to be activated and have the proper signals is a lot to ask at this stage. My opinion is that this paper does not show that the adipose tissue is superior, but it does give us hope and a starting point to further refine these biologic treatments.
Reference:
Xu S, et al. J Orthop. 2019;doi:10.1016/j.jor.2019.11.037.
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