RESUMO
Background: Carboplasty is a new minimally invasive technique for knee osteoarthritis (OA) that consists of injecting tibial marrow aspirate into the bone-cartilage interface as well as intra-articularly. Purpose: To compare the clinical and imaging outcomes, as well as the safety, of carboplasty for symptomatic knee OA in a placebo-controlled trial. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The authors conducted a randomized controlled trial to compare carboplasty with placebo for the treatment of symptomatic knee OA. Patients who had failed medical treatment and had bone edema on magnetic resonance imaging (MRI) were randomized in a 1:1 ratio to carboplasty or placebo. The primary outcome of the study was the Numeric Pain Rating Scale (NPRS) for the knee at 1 year (scores range from 0 to 10, with a higher score indicating worse pain). Secondary outcomes were the Knee injury and Osteoarthritis Outcome Score (KOOS), treatment responder rate (based on achieving the minimal clinically important difference of the NPRS), MRI bone edema reduction, and treatment safety. Results: In total, 50 patients (25 carboplasty vs 25 placebo) were enrolled and followed up with for an average of 18 months (range, 14-24 months). The average NPRS at baseline decreased from 7.1 ± 0.9 to 2.9 ± 2.1 (P < .001) at 1 year in the carboplasty group and from 7.7 ± 0.9 to 4.9 ± 2.2 (P < .001) in the placebo group. On average, patients after carboplasty improved 60% from their initial NPRS, and patients after placebo improved 37% (P = .003). Patients had a statistically significantly greater improvement from baseline in all KOOS subscales in the carboplasty group compared with the placebo group (P < .001). The responder rates were 96% for carboplasty and 76% for placebo (P = .098). Bone edema was reduced in 72% of patients in the carboplasty group and 44% of patients in the placebo group (P = .045). Neither group had adverse events related to treatment. Conclusion: Carboplasty resulted in greater pain reduction, a significantly greater improvement in all KOOS subscales, and a similar safety profile compared with placebo in patients with symptomatic knee OA and bone edema. Registration: ISRCTN69838191 (ISRCT Registry).
