关节镜下人工韧带加强系统重建前交叉韧带

背景:由于人工韧带新材料生产工艺的改进,减少了人工韧带使用后由于材料疲劳而出现的断裂,以及因组织相容性问题出现滑膜炎等并发症的问题,使人工韧带应用更为广泛.目的:评估关节镜下应用人工韧带加强系统(Ligament Advanced Reinforcement System,LARS)重建膝关节前交叉韧带后的组织相容性反应及其临床效果.设计:完全随机临床设计.单位:苏州大学附属第二医院骨科.对象:2005-06/2006-06苏州大学附属第二医院骨科因膝关节前交叉韧带损伤行关节镜下LARS重建人工韧带的手术患者32例,男27例,女13例,平均年龄21岁,均为运动损伤.所有患者术前MRI均显示前交叉韧带损伤并发半月板损伤:患者对治疗内容知情同意.方法:对32例膝关节前交叉韧带损伤患者行关节镜下LARS人工韧带重建.重建韧带应用LARS人工韧带加强系统,由法国LARS公司生产(证书:CE0459,IS09002-EN46002).人工韧带材型为PET-聚对苯二甲酸乙二醇酯,L021201(左膝),L021202(右膝),模仿人体韧带的解剖结构和生物力学原理设计而成AC120 2BL(左膝),AC120 2BR(右膝).国食药监械(进)字2004第3460468号].所有韧带重建均由苏州大学附属第二医院骨科同一组有10年以上资质的医生以同样的技术标准完成,由同一高年资的具有博士生导师、主任医师职称的医生主持,参与手术的医生符合卫生部相关上岗职称规定.治疗及实验方案经医院伦理委员会批准.主要观察指标:①观察人工韧带与患者的生物相容性.②对患者进行平均24个月随访,以Lysholm进行膝关节功能评分,以Tegner评分反映患者主观满意度.结果:32例患者均完成随访:完成18,20,24,28,30个月随访者分别为3,7,8,12,2例.①人工韧带生物相容性观察:患者随访结束时均未出现疼痛,急、慢性滑膜炎,以及韧带断裂和活动明显受限等并发症.②膝关节活动功能状态:平均伸屈活动度0°到128.0°±11.6°.Lysholm膝关节功能评分法平均积分由术前的(45.3±1.31)分提高到术后的(85.6±2.24)分,差异有显著性意义(P<0.05).膝不稳症状消失,前抽屉试验阴性.③Tegner评分也有明显提高.结论:LARS人工韧带用于重建前交叉韧带与宿丰组织相容性良好,重建后患者膝关节功能及主观满意度均得到明显提高.

Arthroscopic reconstruction of the anterior cruciate ligament using ligament advanced reinforcement system artificial ligament

BACKGROUND: The improvement in production technology of new materials including artificial ligament reduces material rupture caused by fatigue and histocompatibility-related synovitis and other complications, leading to a wide application of artificial ligament. OBJECTIVE: To evaluate the histocompatibility and clinical curative effects of reconstruction of the anterior cruciate ligament (ACL) of the knee with ligament advanced reinforcement system (LARS) artificial ligament using arthroscopy. DESIGN: A completely randomized clinical design. SETTING: Department of Orthopedics, Second Affiliated Hospital of Soochow University. PARTICIPANTS: Thirty-two cases of ACL injury received LARS artificial ligament in the Department of Orthopedics, Second Affiliated Hospital of Soochow University From June 2005 to June 2006 and were recruited for this study. The 32 patients averaged 21 years old and were injured in sports. Prior to surgery, MRI showed injury to ACL and semilunar valve in all patients. Written informed consent for therapeutic contents was obtained from each patient. METHODS: Thirty-two patients with injury to ACL of the knee underwent arthroscopic ACL reconstruction. LARS was used to reconstruct the ACL. The LARS was produced by Laboratoire d'Application et de Recherche Scientifique, France (Certification No. CE0459, 1SO9002-EN46002). Artificial ligament was made of polyethylene terephthalate, which had the material type L021201 (left knee) and L021202 (right knee). Artificial ligament was designed to imitate the anatomic structure and biomechanical principle of artificial ligament with specification No. AC120 2BL(left knee) and No. AC120 2BR(right knee). The lot number for artificial ligament in China import 03460468 (in 2004)]. All reconstructions were performed by a group of physicians who have worked for more than 10 years in the Department of Orthopedics, Second Affiliated Hospital of Soochow University and directed by a physician titled with doctor's tutor and chief physician. All included physicians were qualified to perform the surgery. The protocol of treatment was approved by the hospital's Ethics Committee. MAIN OUTCOME MEASURES: Biocompatibility of LARS artificial ligament was observed. Patients were followed up for 24 months on average to score knee function by Lysholm test and subjective satisfaction by Tegner test. RESULTS: All of 32 cases were followed up. The follow-up periods were 18 months (3 cases), 20 months (7 cases), 24 months (8 cases), 28 months (12 cases) and 30 months (2 cases). No complications, such as acute or chronic synovitis, LARS artificial ligament rupture, or limited range of motion were found. The knee joint function was ideal with the range of motion 0° to (128±11.56)°]. The postoperative scores with 85.6 ± 2.24 were significandy higher than the preoperative scores with 45.3±1.31 according to the Lysholm knee joint function evaluation system (P < 0.05). The instability of every knee disappeared with anterior drawer sign negative. Tegner's scores were also increased. CONCLUSION: The biocompatibility of LARS is optimal. LARS artificial ligament reconstruction showed excellent knee joint function and subjective satisfaction degree.