Abstract
BackgroundSpontaneous recovery from articular cartilage injury is difficult, and the ongoing progression of disease can eventually lead to osteoarthritis. Currently, there is no effective non-surgical treatment for articular cartilage injury. Arthroscopic debridement and microfracture surgery are performed for fibrocartilage repair. But fibrocartilage is different from normal articular cartilage, and functional recovery is not satisfactory. Therefore, it is necessary to develop more effective techniques for articular cartilage repair. Progress in material science, cell biology, biomechanics, and bioreactor technology has allowed the development of biomimetic, tissue-engineered osteochondral composites that have shown potential for the repair of damaged cartilage. We prepared biomimetic, tissue-engineered cartilage scaffolds optimized for biochemical composition and structural characteristics. Based on the experience of our pre-clinical studies on animals, a human articular cartilage acellular matrix scaffold was prepared and is in clinical use. The combination of autologous chondrocytes and scaffolds has shown satisfactory results in repairing cartilage defects in preliminary experiments.MethodsThis is a prospective randomized controlled trial. One hundred patients with full-thickness cartilage injury of the knee will be randomly divided into two groups to receive treatment with either tissue-engineered cartilage constructed using biomimetic cartilage extracellular-matrix-oriented scaffolds combined with autologous chondrocytes, or arthroscopic debridement and microfracture surgery. There will be five visiting time points: at baseline, then at 3, 6, 12, and 18 months postoperatively. The primary outcome will be therapeutic efficacy as assessed by the Lysholm score at 12 months postoperatively. The secondary outcomes will be the International Knee Documentation Committee score, Visual Analog Scale score, and cartilage injury and repair as assessed by magnetic resonance imaging as well as the incidence of postoperative adverse events.DiscussionThis trial will attempt to verify the use of tissue-engineered cartilage constructed using autologous chondrocytes combined with allogeneic, acellular cartilage matrix for the repair of cartilage defects, thereby providing favorable evidence for its use in clinical practice.Trial registrationClinicalTrials.gov, identifier: NCT02770209. Registered on 11 May 2016.
Highlights
Spontaneous recovery from articular cartilage injury is difficult, and the ongoing progression of disease can eventually lead to osteoarthritis
The microfracture technique is limited to small-scale damage, and autologous osteochondral transplantation is hindered by limited supply
The secondary objective of the study is to (1) compare the effectiveness of the two repair methods on knee function recovery based on International Knee Documentation Committee (IKDC) scores, (2) compare the effectiveness of the two repair methods on pain relief, (3) assess cartilage regeneration by magnetic resonance imaging (MRI), and (4) compare the safety of the two repair methods for knee cartilage repair
Summary
Spontaneous recovery from articular cartilage injury is difficult, and the ongoing progression of disease can eventually lead to osteoarthritis. It is necessary to develop more effective techniques for articular cartilage repair. Cell biology, biomechanics, and bioreactor technology has allowed the development of biomimetic, tissue-engineered osteochondral composites that have shown potential for the repair of damaged cartilage. The combination of autologous chondrocytes and scaffolds has shown satisfactory results in repairing cartilage defects in preliminary experiments. Effective treatment, damage to the articular cartilage progressively worsens, resulting in joint swelling, pain, and dysfunction. Clinical therapy for cartilage damage includes microfracture surgery and autologous osteochondral transplantation. With advances in material science, cell biology, biomechanics, and bioreactor technology, the new generation of biomimetic, tissue-engineered osteochondral composites display great potential for the repair of cartilage damage [1, 2]
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