Rigidfix横穿钉固定移植肌腱胫骨端重建前交叉韧带的临床研究

目的:探讨Rigidfix横穿钉固定移植肌腱胫骨端重建前交叉韧带的临床疗效和安全性。方法:回顾性分析99例采用自体腘绳肌肌腱重建前交叉韧带(anterior cruciate ligament,ACL)患者的病例资料,其中移植肌腱胫骨端采用Rigidfix横穿钉固定50例(横穿钉固定组)、采用Intrafix界面螺钉固定49例(界面螺钉固定组)。比较2组患者的手术时间、术后至完全负重行走时间、Lysholm评分、国际膝关节文献委员会(International Knee Documentation Committee,IKDC)膝关节评分、胫骨隧道内口扩大值及并发症发生情况。结果:2组患者的手术时间、术后至完全负重行走时间比较,组间差异均无统计学意义(55.3±5.3)min,(53.5±4.3)min,t=1.891,P=0.062;(19.0±5.1)d,(18.3±3.8)d,t=0.741,P=0.461]。所有患者均获得随访,随访时间24~35个月,中位数33个月。切口均甲级愈合。2组患者术后1年Lysholm评分、IKDC膝关节评分比较,组间差异均无统计学意义(90.4±1.7)分,(90.9±1.7)分,t=-1.575,P=0.118;(86.0±3.2)分,(86.1±2.9)分,t=-0.069,P=0.945]。胫骨隧道内口扩大值,横穿钉固定组低于界面螺钉固定组(1.49±0.11)mm,(2.52±0.17)mm,t=-36.488,P=0.000]。横穿钉固定组2例出现横穿钉穿出骨皮质,界面螺钉固定组25例出现螺钉偏移骨隧道,均未做处理,随访期间未见异常。均无膝关节僵硬、神经血管损伤、膝关节感染等并发症发生。横穿钉固定组的并发症发生率低于界面螺钉固定组(χ~2=27.585,P=0.000)。结论:采用自体肌腱重建ACL时,移植肌腱胫骨端采用Rigidfix横穿钉固定和Intrafix界面螺钉固定的短期临床疗效相当,但Rigidfix横穿钉固定安全性更高。

A clinical study of fixation of tibial end of transplanted tendon with Rigidfix cross-pins in surgery of anterior cruciate ligament reconstruction

Objective:To explore the clinical curative effects and the safety of fixation of tibial end of transplanted tendon with Rigidfix cross-pins in surgery of anterior cruciate ligament reconstruction(ACLR).Methods:The medical records of 99 patients who received ACLR with autologous hamstring tendon were analyzed retrospectively.The tibial end of transplanted tendon was fixed with Rigidfix cross-pins in 50 patients(cross-pin fixation group)and Intrafix interference screw in 49 patients(interference screw fixation group)respectively.The operative time,postoperative full weight-bearing walking start time,Lysholm scores,International Knee Documentation Committee(IKDC)knee scores,enlarged value of tibial tunnel entrance and complication incidences were compared between the 2 groups.Results:There was no statistical difference in operative time and postoperative full weight-bearing walking start time between the 2 groups(55.3+/-5.3 vs 53.5+/-4.3 min,t=1.891,P=0.062;19.0+/-5.1 vs 18.3+/-3.8 days,t=0.741,P=0.461).All patients in the 2 groups got primary healing in the surgical incisions and all patients in the 2 groups were followed up for 24-35 months with a median of 33 months.There was no statistical difference in Lysholm scores and IKDC knee scores between the 2 groups at 1 year after the surgery(90.4+/-1.7 vs 90.9+/-1.7 points,t=-1.575,P=0.118;86.0+/-3.2 vs 86.1+/-2.9 points,t=-0.069,P=0.945).The enlarged values of tibial tunnel entrance were lower in cross-pin fixation group compared to interference screw fixation group(1.49+/-0.11 vs 2.52+/-0.17 mm,t=-36.488,P=0.000).The cross-pin punched out of the bone cortex in 2 patients in cross-pin fixation group,and the screw deviated from tibial tunnel in 25 patients in interference screw fixation group.No special treatment was performed and no abnormalities were found during the follow-up period.No complications such as knee joint stiffness,neurovascular injury and knee arthrosis infection were found in the 2 groups.The incidence rate of complications was lower in cross-pin fixation group compared to interference screw fixation group( χ~2= 27. 585,P = 0. 000). Conclusion: Rigidfix cross-pin and Intrafix interference screw are similar to each other in the short-term clinical curative effects of fixation of tibial end of transplanted tendon in surgery of ACLR with autologous tendon,while the former surpasses the latter in safety.