I型胶原基质植入与微骨折治疗膝关节软骨缺损的初步临床与实验研究。
完整摘要 · 中文译文
背景：微骨折术用于治疗软骨缺损，但可能损害软骨下骨的完整性。I型胶原基质植入已成为治疗晚期（Outerbridge III-IV级）病变的潜在替代方案，尽管支持性证据仍然有限。本研究将临床评价与动物模型相结合以验证治疗结果。目的是比较I型胶原基质植入与微骨折术的短期临床疗效和软骨修复质量，并在动物模型中验证临床发现。材料与方法：这项前瞻性、随机、探索性初步转化研究包括动物实验和临床试验。在18只大鼠中制作全层软骨缺损，并分别采用空白对照、微骨折术或I型胶原植入治疗。12周后，进行大体和组织学评价（番红O/固绿染色）。同时，纳入36例膝关节软骨缺损患者进行随机、单盲试验（胶原组，n=20；微骨折组，n=16），并随访12个月。记录术前（仅Lysholm和IKDC）及术后3、6和12个月的Lysholm、国际膝关节文献委员会（IKDC）和磁共振软骨修复组织观察（MOCART）评分。结果：在动物模型中，与对照组和微骨折组相比，I型胶原植入产生了更优的软骨和软骨下骨修复。在临床上，两组均显示出显著改善；胶原组consiste [部分缺失] 获得了更高的功能评分和MOCART评分（P<0.05）。结论：与微骨折术相比，I型胶原基质植入与更有利的软骨再生和更好的短期临床结局相关，是一种有效的生物材料辅助治疗膝关节软骨缺损的策略。
完整摘要 · 英文原文
BACKGROUND Microfracture is used to treat cartilage defects but may compromise subchondral bone integrity. Type I collagen matrix implantation has emerged as a potential alternative for advanced (Outerbridge III-IV) lesions, although supporting evidence remains limited. This study combined clinical evaluation with an animal model to validate treatment outcomes. The aim was to compare short-term clinical efficacy and cartilage repair quality of Type I collagen matrix implantation versus microfracture and to validate clinical findings in an animal model. MATERIAL AND METHODS This prospective, randomized, exploratory pilot translational study included both animal and clinical experiments. Full-thickness cartilage defects were created in 18 rats and treated with a blank control, microfracture, or Type I collagen implantation. After 12 weeks, gross and histological evaluations (Safranin O/Fast Green staining) were performed. Concurrently, 36 patients with knee cartilage defects were enrolled in a randomized, single-blind trial (collagen group, n=20; microfracture group, n=16) and followed for 12 months. Lysholm, International Knee Documentation Committee (IKDC), and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores were recorded preoperatively (Lysholm and IKDC only) and at 3, 6, and 12 months postoperatively. RESULTS In the animal model, Type I collagen implantation produced superior cartilage and subchondral bone repair compared with the control and microfracture groups. Clinically, both groups showed significant improvement; the collagen group consistently achieved higher functional and MOCART scores (P<0.05). CONCLUSIONS Type I collagen matrix implantation was associated with more favorable cartilage regeneration and better short-term clinical outcomes than microfracture, representing an effective biomaterial-assisted treatment strategy for knee cartilage defects.