Lee Dong Hoon, Ryu Keun Jung, Shin Dong Eun, Kim Hyun Woo
Department of Orthopaedic Surgery, Severance Hospital, College of Medicine, Yonsei University, 134 Sinchondong, CPO Box 8044, Seoul, Republic of Korea,
Clin Orthop Relat Res. 2014 Dec;472(12):3835-41. doi: 10.1007/s11999-014-3546-5.
During lower limb lengthening, distraction-induced muscle pain and surrounding joint contractures are frustrating complications for which few effective treatments are available.
QUESTIONS/PURPOSES: We evaluated Botulinum Toxin Type A (BtX-A) injection in the calf muscles during human tibial distraction osteogenesis. We hypothesized that it may decrease calf pain and increase ROM of the surrounding joints by reducing muscle stiffness.
Between April 2010 and January 2011, we evaluated 36 patients undergoing bilateral tibia lengthening who met prespecified inclusion criteria. All patients underwent stature lengthening with lengthening over a nail or lengthening and then nailing. BtX-A (200 IU) was injected at the calf muscle only in one leg for each patient and the same amount of sterile normal saline was injected into the other leg as a control. Selection of the leg receiving the toxin was randomized. Clinical evaluation included a VAS score for calf pain and measurement of ROM of the knees and ankles and calf circumference, with evaluations performed in a double-blinded manner. Side-to-side differences were analyzed until the end of consolidation phase. Minimum followup was 24 months (mean, 30 months; range, 24-39 months). The distraction rate and the final length gain were similar in the treated and control limbs. A priori power analysis suggested that 34 legs were required to achieve statistical significance of 0.05 with 80% of power to detect a 50% difference in treatment effect between treatment and control groups.
There were no differences in calf pain, knee and ankle ROM, and maximal calf circumferences between the two legs at each time point.
Local injection of 200 IU BtX-A at the human calf muscle does not appear to reduce calf pain or help enhance ROM of the knee and ankle during tibial lengthening. However, the small sample size provided sufficient power to detect only relatively large clinical effects; future, larger trials will be needed to determine whether smaller differences are present.
Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.
在下肢延长过程中，牵张诱导的肌肉疼痛和周围关节挛缩是令人困扰的并发症，目前几乎没有有效的治疗方法。
问题/目的：我们评估了A型肉毒杆菌毒素（BtX-A）注射于人体胫骨牵张成骨过程中小腿肌肉的效果。我们假设它可能通过降低肌肉僵硬程度来减轻小腿疼痛并增加周围关节的活动度。
在2010年4月至2011年1月期间，我们评估了36例接受双侧胫骨延长且符合预定纳入标准的患者。所有患者均采用髓内钉延长或先延长再髓内钉固定的方式进行身高延长。每位患者仅在一条腿的小腿肌肉注射200国际单位的BtX-A，另一条腿注射等量的无菌生理盐水作为对照。接受毒素注射的腿的选择是随机的。临床评估包括小腿疼痛的视觉模拟评分（VAS）、膝关节和踝关节活动度的测量以及小腿周长的测量，评估采用双盲方式进行。分析直至巩固期结束时的双侧差异。最短随访时间为24个月（平均30个月；范围24 - 39个月）。治疗组和对照组肢体的牵张速率和最终长度增加相似。预先的功效分析表明，需要34条腿才能在检验效能为80%时达到0.05的统计学显著性，以检测治疗组和对照组之间治疗效果50%的差异。
在每个时间点，两条腿之间的小腿疼痛、膝关节和踝关节活动度以及最大小腿周长均无差异。
在人体小腿肌肉局部注射200国际单位的BtX-A似乎并不能减轻胫骨延长过程中的小腿疼痛或帮助增加膝关节和踝关节的活动度。然而，样本量较小，仅能提供足够的效能来检测相对较大的临床效果；未来需要更大规模的试验来确定是否存在较小的差异。
II级，治疗性研究。有关证据水平的完整描述，请参阅作者指南。
