Hopital Henri Mondor, Paris, France,
Int Orthop. 2013 Dec;37(12):2377-84. doi: 10.1007/s00264-013-2066-3. Epub 2013 Aug 24.
The safety and efficacy of the novel Limmed® system (locked plate fixation) for immediate full weight-bearing after medial opening wedge high tibial osteotomy (HTO) were evaluated in patients with symptomatic varus gonarthrosis.
A case series of 85 consecutive osteotomies performed with Limmed® locked plate fixation for medial opening wedge HTO was compared to a historical matched case-control series of 85 HTOs (85 patients) performed using the same implant without locked screws. Subjects were observed at seven and 15 days and three, six and 12 months after surgery. Endpoints for evaluation included the reporting of adverse events, weight-bearing status without pain, radiographic evidence of bony union and changes in correction angle during healing.
Statistically significant differences were seen between groups in terms of safety (thrombophlebitis), time to weight-bearing, radiographic union and radiographic stability between the two groups. Patients of the Limmed® group reported less thrombophlebitis (one versus nine), outcome with shorter time for full weight-bearing (average 45 days difference, p = 0.01) and a shorter time for union (average four weeks difference). At the one-year follow-up the post-operative hip-knee-ankle angle was 4.2° of valgus in the Limmed® group and 2° of valgus in the control group. The adjusted mean difference of 2.2° was significant (p = 0.02) and related to loss of correction during healing in the control group with difference in implant stability. The severity of pain, knee score and walking ability improved in both groups with a significant difference before the third month (quicker for Limmed® group), while at the most recent follow-up only the difference for mobility in flexion was significant.
The Limmed® medial opening wedge HTO system represents a novel method of achieving a reliable correction while producing a stable fixation allowing satisfactory stability and bone healing with immediate full weight-bearing.
评估新型 Limmed® 系统（锁定钢板固定）在伴有症状性内翻性膝关节炎的患者中行内侧开放楔形胫骨高位截骨术（HTO）后即刻完全负重的安全性和疗效。
对 85 例连续接受 Limmed® 锁定钢板固定内侧开放楔形 HTO 的患者进行病例系列研究，并与 85 例接受相同植入物但未使用锁定螺钉的内侧开放楔形 HTO 的历史匹配病例对照系列进行比较。术后 7 天、15 天和 3 个月、6 个月、12 个月观察受试者。评估的终点包括不良事件报告、无疼痛负重状态、影像学骨愈合证据和愈合过程中矫正角度的变化。
两组在安全性（血栓性静脉炎）、负重时间、影像学愈合和影像学稳定性方面存在统计学显著差异。Limmed® 组患者报告的血栓性静脉炎较少（1 例与 9 例），完全负重的时间更短（平均差异 45 天，p = 0.01），愈合时间更短（平均差异 4 周）。在 1 年随访时，Limmed® 组的术后髋膝踝角为 4.2°外翻，对照组为 2°外翻。调整后的平均差值 2.2°具有统计学意义（p = 0.02），这与对照组在愈合过程中矫正丢失有关，与植入物稳定性差异有关。两组的疼痛严重程度、膝关节评分和步行能力均有改善，在第三个月前有显著差异（Limmed® 组更快），而在最近的随访中，只有膝关节弯曲活动度的差异具有统计学意义。
Limmed® 内侧开放楔形 HTO 系统是一种可靠的矫正方法，同时产生稳定的固定，允许满意的稳定性和骨愈合，可即刻完全负重。
