Arthroscopic Subchondral Drilling Followed by Injection of Peripheral Blood Stem Cells and Hyaluronic Acid Showed Improved Outcome compared to Hyaluronic acid and Physiotherapy for Massive Knee Chondral Defects: A Randomized Controlled Trial.

Abstract

PURPOSE\nThe purpose of this study was to evaluate the safety and efficacy of intra-articular injections of autologous peripheral blood stem cells (PBSC) plus hyaluronic acid (HA) after arthroscopic subchondral drilling into massive chondral defects of the knee joint and to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than HA plus physiotherapy.\n\n\nMETHODS\nThis is a dual centre randomized controlled trial (RCT). Sixty-nine patients age 18-55 years with International Cartilage Repair Society (ICRS) grade 3 and 4 chondral lesions (size ≥ 3cm2) of the knee joint were randomized equally into (i) control group receiving intra-articular injections of HA plus physiotherapy and (ii) intervention group receiving arthroscopic subchondral drilling into chondral defects and postoperative intra-articular injections of PBSC plus HA. The co-primary efficacy endpoints were subjective International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS)-pain subdomain measured at Month 24. The secondary efficacy endpoints included all other KOOS subdomains, Numeric Rating Scale (NRS) and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores.\n\n\nRESULTS\nAt 24 months, the mean IKDC scores for the control and intervention groups were 48.1 and 65.6, respectively (P < 0.0001). The mean for KOOS-pain subdomain scores were 59.0 (control) and 86.0 (intervention) with P < 0.0001. All other KOOS subdomains, NRS and MOCART scores were statistically significant (P < 0.0001) at Month 24. Moreover, for the intervention group, 70.8% of subjects had IKDC and KOOS-pain subdomain scores exceeding the minimal clinically important difference (MCID) values, indicating clinical significance. There were no notable adverse events that were unexpected and related to the study drug or procedures.\n\n\nCONCLUSIONS\nArthroscopic marrow stimulation with subchondral drilling into massive chondral defects of the knee joint followed by postoperative intra-articular injections of autologous PBSC plus HA is safe and showed a significant improvement of clinical and radiological scores as compared to HA plus physiotherapy.\n\n\nLEVEL OF EVIDENCE\nLevel I, RCT.