Departamento de Ortopedia e Traumatologia, Escola Paulista de Medicina, Rua Borges Lagoa, 783 5° Andar, São Paulo, SP, CEP 04038-031, Brazil.
Knee Surg Sports Traumatol Arthrosc. 2018 Oct;26(10):2934-2941. doi: 10.1007/s00167-018-4834-5. Epub 2018 Jan 15.
The treatment approach for a patient with knee joint focal cartilage lesion is a difficult decision. To date, there has been no randomized clinical trial involving Hydrogel (Cartiva™). This study evaluated and compared the results of a hydrogel implant (Cartiva™) with autologous osteochondral transplantation (AOT) for treating knee joint focal cartilage lesions.
Thirty-eight symptomatic patients, with a focal cartilage lesion of Outerbridge grades III or IV, were randomized into one of two groups according to the inclusion and exclusion criteria. Group I underwent AOT, and Group II was treated with a Hydrogel implant. Patients were evaluated preoperatively and again postoperatively at 6, 12, and 24 months using the subjective International Knee Documentation Committee (IKDC) scores, Visual Analog Scale for Pain (VAS Pain), Activities of Daily Living Scale (ADLS) and Lysholm score.
Both groups showed significant improvements from baseline (pre-surgery) to post-surgery (6, 12, and 24 months; p < 0.05), but there was no difference between the groups. Regarding complications, prolonged pain was observed in four patients (10.5%), two from each group, with a regression of symptoms within 1 year.
The Hydrogel implant showed similar efficiency as the autologous osteochondral graft for treating knee joint focal cartilage lesions. Both techniques showed satisfactory results compared to preoperative status. The Hydrogel implant was safe and effective, and it provided good stability and joint function at 2-year follow-up.
I.
膝关节局灶性软骨病变患者的治疗方法是一个困难的决策。迄今为止，尚无涉及 Hydrogel（Cartiva™）的随机临床试验。本研究评估并比较了 Hydrogel 植入物（Cartiva™）与自体软骨移植（AOT）治疗膝关节局灶性软骨病变的结果。
根据纳入和排除标准，38 例有Outerbridge 分级 III 或 IV 级局灶性软骨病变的症状性患者被随机分为两组。组 I 行 AOT，组 II 行 Hydrogel 植入物治疗。患者在术前和术后 6、12 和 24 个月分别采用国际膝关节文献委员会（IKDC）主观评分、疼痛视觉模拟量表（VAS 疼痛）、日常生活活动量表（ADLS）和 Lysholm 评分进行评估。
两组均从基线（术前）到术后（6、12 和 24 个月；p<0.05）有显著改善，但两组之间无差异。关于并发症，有 4 例（10.5%）患者出现持续疼痛，每组 2 例，症状在 1 年内消退。
Hydrogel 植入物在治疗膝关节局灶性软骨病变方面与自体软骨移植物具有相似的效果。与术前相比，两种技术均取得了令人满意的结果。Hydrogel 植入物安全有效，在 2 年随访时提供了良好的稳定性和关节功能。
I 级。
