胫骨干骨折的髓内钉固定与外固定架固定：来自IMVEX试验的肌肉力量探索性分析

Intramedullary nailing versus external ring fixation for tibial shaft fractures: an explorative analysis of muscle strength from the IMVEX trial.

作者信息

Larsen Peter, Stokholm Rasmus, Rölfing Jan Duedal, Petruskevicius Juozas, Rasmussen Morten Kjerri, Jensen Steffen Skov, Elsoe Rasmus

机构信息

Aalborg University Hospital, Aalborg, Denmark.

Aarhus University Hospital, Aarhus, Denmark.

出版信息

Arch Orthop Trauma Surg. 2025 Jul 18;145(1):379. doi: 10.1007/s00402-025-05995-6.

DOI:10.1007/s00402-025-05995-6

PMID:40679543

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12274231/

Abstract

BACKGROUND

To explore the effect of intramedullary nailing versus external ring fixation for patients with tibial shaft fractures on 12-month maximal isometric muscle strength for knee extension and knee flexion. We hypothesise that patients treated with external ring fixation will show significantly better maximal isometric muscle strength for knee extension and knee flexion 12 months after surgery compared to treatment with intramedullary nailing. Moreover, we aim to explore the association between muscle strength and the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months following surgery.

METHODS

A pragmatic multicentre randomised, non-blinded trial with a two-group parallel design. This study is an explorative analysis of the IntraMedullary nailing Versus EXternal ring fixation Trial (IMVEX). 67 patients with a tibial shaft fracture were randomized to external ring fixation or intramedullary nailing. The primary outcome: maximal isometric muscle strength for knee extension and knee flexion. Secondary outcome was KOOS.

RESULTS

No statistically significant difference in muscle strength between treatment with intramedullary nailing and external ring fixation was observed (P < 0.31). Examination of maximal isometric muscle strength showed significant difference between the injured and the non-injured leg (knee extension: mean difference of 53N, (95%CI 33.9-72.4), knee flexion: mean difference of 35N, (95%CI 21.2-47.9)) The association between KOOS subscale scores and the relative difference in muscle strength for knee extension showed significant and moderate to high correlation (0.4-0.8) for all subscales.

CONCLUSION

Muscle strength of knee flexion and extension was markedly decreased one year after fracture. We observed no statistically significant difference in recovery of muscle strength between treatment with intramedullary nailing and external ring fixation. Results indicate that a decrease in muscle strength is associated with worse patient-reported outcomes for all five KOOS subscales.

TRIAL REGISTRATION

NCT03945669.

LEVEL OF EVIDENCE

II.

摘要

背景

探讨胫骨干骨折患者采用髓内钉固定与外固定架固定对术后12个月膝关节伸展和屈曲的最大等长肌力的影响。我们假设，与髓内钉固定治疗相比，采用外固定架固定治疗的患者在术后12个月时膝关节伸展和屈曲的最大等长肌力表现会显著更好。此外，我们旨在探究术后12个月时肌肉力量与膝关节损伤和骨关节炎疗效评分（KOOS）之间的关联。

方法

一项采用两组平行设计的实用多中心随机非盲试验。本研究是对髓内钉固定与外固定架固定试验（IMVEX）的探索性分析。67例胫骨干骨折患者被随机分为外固定架固定组或髓内钉固定组。主要结局指标：膝关节伸展和屈曲的最大等长肌力。次要结局指标为KOOS。

结果

未观察到髓内钉固定治疗与外固定架固定治疗在肌肉力量方面存在统计学显著差异（P < 0.31）。最大等长肌力检查显示，受伤腿与未受伤腿之间存在显著差异（膝关节伸展：平均差异53N，（95%可信区间33.9 - 72.4），膝关节屈曲：平均差异35N，（95%可信区间21.2 - 47.9））。KOOS各分量表评分与膝关节伸展肌肉力量相对差异之间的关联在所有分量表中均显示出显著且中等至高的相关性（0.4 - 0.8）。