RESUMO
Background: The purpose of the present observational multicentric prospective study was to evaluate the efficacy and safety of a new infiltration device (CHondroGrid, Bioteck S.p.A, Arcugnano, Italy) based on hydrolyzed collagen in the treatment of rotator cuff tendinopathy. Methods: Seventy-one patients (53.3 ± 11.6 years old) affected by rotator cuff tendinopathy were treated in 2021 with two subacromial injections of CHondroGrid at 13 ± 2.9 days apart. The outcomes measured were the visual analog scale (VAS) score (in movement, during the night, and at rest), the Constant Score, the Simple Shoulder Test, and patient satisfaction. The outcome variables were measured before each injection, at 1 month and at 6 months after the last injection. Results: The treatment was significantly effective from the first injection and up to the six-month follow-up. At the last follow-up, the VAS score on movement had improved by 71% (P < .001), while the VAS score at rest and during the night had ameliorated by 91% and 87%, respectively (P < .001). The Constant Score and Simple Shoulder Test improved by 32% and 61%, respectively (P < .001). No adverse events were reported. Conclusions: CHondroGrid resulted in a safe and effective treatment in pain relief and for the functional recovery of rotator cuff tendinopathy.
RESUMO
BACKGROUND: Glenohumeral osteoarthritis (GOA) is associated with disabling shoulder pain that affects everyday life. Its management comprises various treatment approaches, both conservative and surgical. Regenerative medicine has gained a major role in the conservative treatment of osteoarthritis. Intra-articular injection of adipose-derived mesenchymal stem cells (ADMSCs) is a widely used regenerative medicine approach. The aim of this retrospective study was to report the safety and clinical outcomes of intra-articular injection of ADMSCs in patients with GOA over 36-months. METHODS: This retrospective observational study involved patients with chronic shoulder pain resistant to standard conservative treatment and a diagnosis of concentric GOA, who received an intra-articular injection of autologous micro-fragmented adipose tissue (µFAT). The values of the Constant-Murley score (CMS), the visual analog scale (VAS), and the simple shoulder test (SST), collected at baseline and at 12, 24, and 36 months, were analyzed to assess treatment efficacy. The single assessment numeric evaluation (SANE) was used to rate patient satisfaction. The Friedman test was used to compare observations of CMS, VAS, and SST values repeated on the same subjects. The significance threshold was set at 0.05. RESULTS: The participants were 65 patients with a mean age of 54.19 years and a nearly equal gender distribution. Most had mild concentric GOA classified as Samilson-Prieto grade 1. The mean follow-up duration was 44.25 months. The postoperative clinical scores showed significant improvement. At 36 months, the CMS was 84.60, the VAS score was 3.34, and the SST score was 10.15 (all p < 0.0001). The SANE score at 36 months indicated that 54 patients (83.08%) were completely satisfied with the treatment. CONCLUSION: ADMSC treatment exerted favorable effects on the clinical outcomes of patients with GOA, providing pain relief and improving shoulder function. Our data support its use as a conservative treatment option for osteoarthritis.