Salvatore Bisicchia1,2, Gabriele Bernardi3, Susanna M Pagnotta3, Cosimo Tudisco3. 1. Applied Biotechnologies and Translational Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy. s.bisicchia@gmail.com. 2. Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy. s.bisicchia@gmail.com. 3. Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
Abstract
PURPOSE: To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated withmicro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone. METHODS:Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption. RESULTS: All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03). CONCLUSIONS:Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs. LEVEL OF EVIDENCE: Level 1-therapeutic study.
RCT Entities:
PURPOSE: To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone. METHODS: Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption. RESULTS: All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03). CONCLUSIONS: Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs. LEVEL OF EVIDENCE: Level 1-therapeutic study.