Abstract：
OBJECTIVE: The goal of this trial was to determine whether coronal plane angulation affects functional and clinical outcomes after the fixation of distal femur fractures.
METHODS: Multicenter, randomized controlled trial SETTING: 20 academic trauma centers PATIENTS/PARTICIPANTS: 156 patients with distal femur fractures were enrolled. 123 patients were followed 12 months. There was clinical outcome data available for 105 patients at 3 months, 95 patients at 6 months and 81 patients at one year.
METHODS: Lateral locked plating or retrograde intramedullary nailing MAIN OUTCOME MEASUREMENTS: Radiographic alignment, functional scoring including SMFA, Bother Index, and EQ-5D. Clinical scoring of walking ability, need for ambulatory support and ability to manage stairs.
RESULTS: At 3 months, there was no difference between groups (varus, neutral or valgus) with respect to any of the clinical functional outcome scores measured. At 6 months, compared to those with neutral alignment, patients with varus angulation had a worse Stair Climbing score (4.33 vs. 2.91, p = 0.05). At 12 months, the average patient with neutral or valgus alignment needed less ambulatory support than the average patient in varus. Walking distance ability was no different between the groups at any time point. With respect to the validated patient-based outcome scores, we found no statistical difference in in the SMFA, Bother, or EQ-5D between patients with valgus or varus mal-alignment and those with neutral alignment at any time point (p > 0.05). Regardless of coronal angulation, the SMFA trended towards lower (improved) scores over time, while EQ-5D scores for patients with varus angulation did not improve over time.
CONCLUSIONS: Valgus angulation and neutral angulation may be better tolerated in terms of clinical outcomes like stair climbing and need for ambulatory support than varus angulation, though patient reported outcome measures like the SMFA, Bother Index and EQ-5D show no statistical significance. Most patients with distal femur fractures tend to improve during the first year after injury but many remain significantly affected at 12 months post injury.
METHODS: Multicenter, randomized controlled trial SETTING: 20 academic trauma centers PATIENTS/PARTICIPANTS: 156 patients with distal femur fractures were enrolled. 123 patients were followed 12 months. There was clinical outcome data available for 105 patients at 3 months, 95 patients at 6 months and 81 patients at one year.
METHODS: Lateral locked plating or retrograde intramedullary nailing MAIN OUTCOME MEASUREMENTS: Radiographic alignment, functional scoring including SMFA, Bother Index, and EQ-5D. Clinical scoring of walking ability, need for ambulatory support and ability to manage stairs.
RESULTS: At 3 months, there was no difference between groups (varus, neutral or valgus) with respect to any of the clinical functional outcome scores measured. At 6 months, compared to those with neutral alignment, patients with varus angulation had a worse Stair Climbing score (4.33 vs. 2.91, p = 0.05). At 12 months, the average patient with neutral or valgus alignment needed less ambulatory support than the average patient in varus. Walking distance ability was no different between the groups at any time point. With respect to the validated patient-based outcome scores, we found no statistical difference in in the SMFA, Bother, or EQ-5D between patients with valgus or varus mal-alignment and those with neutral alignment at any time point (p > 0.05). Regardless of coronal angulation, the SMFA trended towards lower (improved) scores over time, while EQ-5D scores for patients with varus angulation did not improve over time.
CONCLUSIONS: Valgus angulation and neutral angulation may be better tolerated in terms of clinical outcomes like stair climbing and need for ambulatory support than varus angulation, though patient reported outcome measures like the SMFA, Bother Index and EQ-5D show no statistical significance. Most patients with distal femur fractures tend to improve during the first year after injury but many remain significantly affected at 12 months post injury.
摘要：
目的：本试验的目的是确定冠状面成角度是否影响股骨远端骨折固定后的功能和临床结果。
方法：多中心，随机对照试验地点:20个学术创伤中心患者/参与者:156例股骨远端骨折患者纳入研究.123例患者随访12个月。3个月时有105例患者的临床结果数据，6个月时95例，1年时81例。
方法：侧向锁定板或逆行髓内钉主要结果测量：射线照相对准，功能评分，包括SMFA，烦恼指数，还有EQ-5D.步行能力的临床评分，需要动态支持和管理楼梯的能力。
结果：在3个月时，组间没有差异(varus，中性或外翻）相对于所测量的任何临床功能结果评分。6个月时,与那些中立对齐的人相比，内翻角度患者的爬楼梯评分较差(4.33vs.2.91,p=0.05)。12个月时,中性或外翻对准的平均患者需要的卧床支持比内翻对准的平均患者少.在任何时间点，两组之间的步行距离能力没有差异。关于验证的基于患者的结果评分，我们发现在SMFA中没有统计学差异，烦恼,或EQ-5D在任何时间点外翻或内翻不对准的患者与中性对准的患者之间（p>0.05）。不管日冕角度如何，随着时间的推移，SMFA分数趋于降低(提高)，而内翻角化患者的EQ-5D评分并没有随着时间的推移而改善。
结论：在爬楼梯和需要卧床支撑的临床结果方面，外翻角度和中性角度可能比内翻角度更好，尽管患者报告了像SMFA这样的结果指标，Bether指数和EQ-5D没有统计学意义。大多数股骨远端骨折患者在受伤后的第一年往往会有所改善，但许多患者在受伤后12个月仍受到显着影响。
方法：多中心，随机对照试验地点:20个学术创伤中心患者/参与者:156例股骨远端骨折患者纳入研究.123例患者随访12个月。3个月时有105例患者的临床结果数据，6个月时95例，1年时81例。
方法：侧向锁定板或逆行髓内钉主要结果测量：射线照相对准，功能评分，包括SMFA，烦恼指数，还有EQ-5D.步行能力的临床评分，需要动态支持和管理楼梯的能力。
结果：在3个月时，组间没有差异(varus，中性或外翻）相对于所测量的任何临床功能结果评分。6个月时,与那些中立对齐的人相比，内翻角度患者的爬楼梯评分较差(4.33vs.2.91,p=0.05)。12个月时,中性或外翻对准的平均患者需要的卧床支持比内翻对准的平均患者少.在任何时间点，两组之间的步行距离能力没有差异。关于验证的基于患者的结果评分，我们发现在SMFA中没有统计学差异，烦恼,或EQ-5D在任何时间点外翻或内翻不对准的患者与中性对准的患者之间（p>0.05）。不管日冕角度如何，随着时间的推移，SMFA分数趋于降低(提高)，而内翻角化患者的EQ-5D评分并没有随着时间的推移而改善。
结论：在爬楼梯和需要卧床支撑的临床结果方面，外翻角度和中性角度可能比内翻角度更好，尽管患者报告了像SMFA这样的结果指标，Bether指数和EQ-5D没有统计学意义。大多数股骨远端骨折患者在受伤后的第一年往往会有所改善，但许多患者在受伤后12个月仍受到显着影响。
