Resurfacing system helps preserve joints
By Peter Pollack
Treatment of full-thickness femoral condyle cartilage lesions in middle-aged patients is a challenging prospect, because biologic treatments often demonstrate less than favorable results.
According to poster exhibit P205, a multicenter clinical trial found that a novel femoral resurfacing system called HemiCAP™preserves joints by removing only minimal amounts of bone and healthy cartilage.
The use of HemiCAP for the femoral condyle is currently being tested under a Food and Drug Administration (FDA) multicenter trial and is not approved for marketing in the United States. HemiCAP™ is FDA-approved for use in the shoulder, hip, great toe, and patellofemoral joint.
HemiCAP™ allows for intra-operative joint geometry mapping and placement of a matched contoured articular prosthetic. Researchers, led by Anthony A. Schepsis, MD of Boston, found excellent pain relief and functional improvement in short-term results. On the WOMAC scale, pain, stiffness, function and global scores all improved by more than 70 percent.
The study consisted of 32 patients (22 males and 10 females), ranging in age from 31 years to 67 years (mean age: 47 years old). Thirty patients were treated on the medial femoral condyle and two were treated on the lateral femoral condyle. Patients who had additional cartilage defects greater than grade 2 or malalignment greater than 7° were excluded; maximum body mass index was less than 30 kg/m2.
Researchers collected WOMAC scores preoperatively and at 3, 6, 12 and 24 months postoperatively. Two patients have been followed for 24 months, 15 patients for 12 months, 5 patients for 6 months, 1 patient for 3 months and 9 patients are scheduled for their first 3-month scoring.
Global scores improved by 83 percent (from an average 1538 preoperatively to an average of 253 at last follow-up).
An independent radiologist confirmed that there were no signs of device migration, device disassembly, or radiolucency around the fixation and the articular component.
Additional researchers on the team include John W. Uribe, MD, and John Zvijac, MD, both of Miami; Bryan Kelly of New York City; Annunziato Amendola, MD, of Iowa City, Iowa; Joshua A. Siegel, MD, of Exeter, N.H.; Frederick C. Flandry, MD, of Columbus, Ga.; Robert Buonanno, MD, and David Moss, MD, of Johnston, R.I.; Robert Litchfield, MD, of London, Ontario, Canada; Richard Parker, MD, Wael Barsoum, MD, and Anthony Miniaci, MD, FRCSC, all of Cleveland, Ohio. The multicenter clinical trial was sponsored by Arthrosurface.