A multi-center study of repairing articular cartilage defects of the knee using cultured autologous chondrocytes

背景:由于关节软骨再生修复能力有限,自体软骨细胞移植技术为关节软骨损伤的修复提供了较好的修复材料。目的:多中心评估自体软骨细胞移植的短期疗效与安全性。设计、时间及地点:自身前后对照观察,于2001-03/2006-04在韩国80所附属医院完成。对象:软骨缺损患者261例,男169例,女92例,年龄15～70岁,平均36.47岁。软骨缺损面积2.0～20.0cm2。其中股骨髁损伤215例,滑车30例,髌骨25例,胫骨2例。方法:取关节非负重区软骨组织200～300mg,体外培养扩增后将软骨细胞植入患者关节缺损区。于移植后6个月对所有患者进行随访,膝关节功能评估标准采用美国膝关节协会评分系统[Knee society score-A(KSS-A)和Knee society score-B(KSS-B)]。主要观察指标:自体软骨细胞膝关节缺损区移植后KSS-A和KSS-B评分。结果:获得随访患者261例。患者移植前KSS-A评分为63.55±18.47,移植后6个月为88.74±11.47,差异有显著性意义(P<0.05)移植前KSS-B评分为59.56±24.92,移植后6个月为85.13±14.67,差异有显著性意义(P<0.05)。患者移植前后膝关节疼痛、活动度、前后稳定性、屈曲挛缩、伸直迟滞、行走能力和上下楼能力均明显改善(P<0.05)。综合评价移植有效率为97.3%,优良率为89.3%。结论:自体软骨细胞移植可有效的治疗关节软骨缺损,促进膝关节功能的恢复。

BACKGROUND： The regeneration ability of articular cartilage is limited. However, the emerging of tissue regeneration based on the use of autologous cells appears to offer great promise in repairing articular cartilage defects.OBJECTIVE： To evaluate the short-term effectiveness and safety of autologous chondrocyte implantation （ACI）.DESIGN, TIME AND SETTING： A prospective study was performed at the eighty university hospitals and general hospitals in Korea from March 2001 to April 2006.PARTICIPANTS： Two hundred and sixty-one patients with articular cartilage injury of the knee were selected, including 169 males,92 females, with the mean age of 36.47 years （ranged： 15-70 years old）, and the mean size of chondral defect was 4.91 cm2 （ranged： 2.0-20.0 cm2）. Totally 215 cases were femoral condyle injury, 30 cases with trochlear, 25 cases with patellar, and 2 cases with tibia defects.METHODS： A total of 200-300 mg of cartilage tissue was obtained from a non-weight-bearing portion of the knee, followed by in vitro culture and implanted into defect of articular cartilage. All cases received a 6-month follow-up, and improvement of knee society score after ACI was evaluated by Knee Society Score-A （KSS-A） and Knee Society Score-B （KSS-B） system.MAIN OUTCOME MEASURES： KSS-A and KSS-B score of defected areas after ACI.RESULTS： All patients received followed-up without any loss. The KSS-A was 63.55±18.47 and 88.74±11.47 prior to and at 6 months after implantation, the difference had significance （P 〈 0.05）. The KSS-B was 59.56±24.92 and 85.13±14.67 respectively prior to and at 6 months after implantation, which had obviously difference （P 〈 0.05）. The joint pain, activity, stability, flexion contracture, locomotor activity and stair climbing were obviously improved. The effective rate was 97.3% and excellent and good rate was 89.3%.CONCLUSION： ACI can achieve a good result in treating knee articular cartilage defects, which can encourage the recover of knee function.