Park Hoon, Shin Soowan, Shin Han Sol, Kim Hyun Woo, Kim Dong Wook, Lee Dong Hoon
Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Biological Sciences, University of Southern California, Los Angeles, CA, USA.
Clin Orthop Relat Res. 2016 Dec;474(12):2705-2711. doi: 10.1007/s11999-016-5018-6. Epub 2016 Aug 9.
Reduced joint ROM and distraction-induced pain are common complaints of patients who have undergone gradual femoral lengthening. Attempts to reduce the effects of lengthening on joint motion have included the use of botulinum toxin to reduce the muscle forces that restrict motion. The benefits of this approach during femoral lengthening, however, have not been conclusively established.
QUESTIONS/PURPOSES: We wished to evaluate the effects of botulinum toxin type A (BtX-A) injection in the anterior thigh muscles during femoral distraction osteogenesis on adjacent joint ROM and distraction-induced pain. We asked: (1) Does injection of BtX-A in the quadriceps muscles lead to improved knee and hip motion during femoral lengthening? (2) Does injection of BtX-A reduce pain during femoral lengthening?
A single-center, double-blind, randomized placebo-controlled trial was conducted. Forty-four patients (88 femurs) undergoing bilateral femoral lengthening for familial short stature were included in the study. BtX-A (200 IU) was injected intraoperatively in the quadriceps muscles of one thigh. An equal volume of sterile normal saline was injected in the other thigh as a control. Selection of the limb receiving the toxin was randomized. Clinical evaluation included a VAS score for pain measurement, ROM evaluation of the hips and knees, and measurement of thigh circumference. Side-to-side differences were analyzed throughout the entire consolidation phase. No patients were lost to followup, leaving 44 patients (88 femurs). The mean followup was 26 months (range, 14-40 months). The distraction rate and final length of gain were similar between treated and control limbs. A priori power analysis suggested that 44 legs were required in each group to achieve statistical significance of 0.05 with 90% power to detect a 50% difference in treatment effect between treatment and control groups.
There were no differences in hip ROM, knee ROM, or maximal thigh circumference between the two lower extremities at any time during the study period. VAS scores were no different between the patients who received BtX-A and those who received saline.
Local injection of 200 IU BtX-A in the quadriceps muscles does not appear to reduce distraction-induced pain nor enhance ROM in the hip or knee during femoral lengthening. Additional studies are needed to evaluate the effect of larger doses or different injection methods. Based on our findings, we do not recommend routine use of botulinum injections during limb lengthening and believe any further use of this drug should only be in the context of a controlled trial.
Level II, therapeutic study.
关节活动度降低和牵张诱导疼痛是接受股骨逐渐延长术患者的常见主诉。为减轻延长术对关节活动的影响，人们尝试使用肉毒杆菌毒素来降低限制活动的肌肉力量。然而，这种方法在股骨延长术中的益处尚未得到确凿证实。
问题/目的：我们希望评估在股骨牵张成骨过程中，向大腿前侧肌肉注射A型肉毒杆菌毒素（BtX-A）对相邻关节活动度和牵张诱导疼痛的影响。我们提出以下问题：（1）在股骨延长过程中，向股四头肌注射BtX-A是否能改善膝关节和髋关节的活动？（2）注射BtX-A是否能减轻股骨延长过程中的疼痛？
进行了一项单中心、双盲、随机安慰剂对照试验。纳入44例因家族性身材矮小接受双侧股骨延长术的患者（88侧股骨）。术中在一侧大腿的股四头肌中注射200 IU的BtX-A。在另一侧大腿注射等量的无菌生理盐水作为对照。随机选择接受毒素注射的肢体。临床评估包括疼痛测量的视觉模拟评分（VAS）、髋关节和膝关节活动度评估以及大腿周长测量。在整个骨愈合阶段分析双侧差异。无患者失访，最终纳入44例患者（88侧股骨）。平均随访时间为26个月（范围14 - 40个月）。治疗组和对照组肢体的牵张速率和最终延长长度相似。预先的功效分析表明，每组需要44条腿才能在检验效能为9power to detect a 50% difference in treatment effect between treatment and control groups.
在研究期间的任何时间，双下肢之间的髋关节活动度、膝关节活动度或最大大腿周长均无差异。接受BtX-A的患者与接受生理盐水的患者之间的VAS评分无差异。
在股四头肌中局部注射200 IU BtX-A似乎不能减轻股骨延长过程中的牵张诱导疼痛，也不能增加髋关节或膝关节的活动度。需要进一步研究评估更大剂量或不同注射方法的效果。基于我们的研究结果，我们不建议在肢体延长术中常规使用肉毒杆菌毒素注射，并且认为该药物的任何进一步使用都应仅在对照试验的背景下进行。
II级，治疗性研究。
