BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial

Cartilage - Tập 6 Số 2 - Trang 62-72 - 2015
Matthew S. Shive1, William D. Stanish2, Robert G. McCormack3, Francisco Forriol4, Nicholas Mohtadi5, Stéphane Pelet6, Jacques Desnoyers7, Stéphane Méthot1, Kendra Vehik8, Alberto Restrepo1
1Piramal Healthcare (Canada) Ltd., Laval, Quebec, Canada.
2Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada
3Department of Orthopedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
4School of Medicine, CEU San Pablo University, Madrid, Spain
5University of Calgary Sports Medicine Centre, Calgary, Alberta, Canada
6Department of Orthopedics, CHA-Pavillon Enfant-Jésus, Quebec, Quebec, Canada
7Hôpital Charles LeMoyne, Greenfield Park, Quebec, Canada
8Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, USA.

Tóm tắt

Objective The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes. Design The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment or microfracture alone, and followed standardized 12-week rehabilitation. Co-primary endpoints of repair tissue quantity and quality were evaluated by 3-dimensional MRI quantification of the degree of lesion filling (%) and T2 relaxation times. Secondary endpoints were clinical benefit measured with WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionnaires and safety. General estimating equations were used for longitudinal statistical analysis of repeated measures. Results Blinded MRI analysis demonstrated that BST-CarGel®-treated patients showed a significantly greater treatment effect for lesion filling ( P = 0.017) over 5 years compared with microfracture alone. A significantly greater treatment effect for BST-CarGel® was also found for repair tissue T2 relaxation times ( P = 0.026), which were closer to native cartilage compared to the microfracture group. BST-CarGel® and microfracture groups showed highly significant improvement at 5 years from pretreatment baseline for each WOMAC subscale ( P < 0.0001), and there were no differences between the treatment groups. Safety was comparable for both groups. Conclusions BST-CarGel® was shown to be an effective mid-term cartilage repair treatment. At 5 years, BST-CarGel® treatment resulted in sustained and significantly superior repair tissue quantity and quality over microfracture alone. Clinical benefit following BST-CarGel® and microfracture treatment were highly significant over baseline levels.

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Cartilage

Tập 6 Số 2

62-72

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