International orthopaedics · 2025
Vibration-stimulation device-assisted enhanced recovery after lower limb fracture surgery: A randomized controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Shi Tai-Long, Yang Zhen-Bang, Zhang Yu-Qin, Fan Zi-Xi, Ding Kai, Jia Si-Ming, Wang Juan, Di Lu-Qing, Chen Wei
Аннотация
OBJECTIVE: In the context of the widespread implementation of enhanced recovery after surgery (ERAS) in orthopaedics, postoperative supportive interventions for patients with lower limb fractures remain limited. This study aimed to introduce a vibration-stimulation device designed in accordance with ERAS principles and to evaluate its clinical effectiveness.
METHODS: This prospective randomized controlled trial consecutively screened 1,241 patients aged 18-75 years with lower limb fractures admitted to a tertiary university-affiliated orthopaedic hospital between January and December 2024, of whom 707 met the inclusion criteria. Patients were randomly assigned in a 1:1 ratio by a random number table to a vibration group or a blank control group. The primary outcomes were the seven day postoperative pain visual analogue scale (VAS) score and the incidence of lower limb deep vein thrombosis (DVT). Secondary outcomes were radiographic fracture-healing time and postoperative functional scores. The primary analysis followed the intention-to-treat (ITT) principle, comparing all randomized patients with available outcome data according to their original allocation, and a per-protocol (PP) sensitivity analysis was additionally performed.
RESULTS: A total of 707 patients completed six to 12 months of follow-up and were included in the ITT analysis (350 in the vibration group and 357 in the control group). In the overall population, the seven day postoperative incidence of lower limb DVT was significantly lower in the vibration group than in the control group [10.9% (38/350) vs 22.6% (81/357); absolute risk difference (ARD) = 11.7%]. The seven day postoperative pain scores were lower in the vibration group (weighted mean approximately 5.1 vs 5.7), radiographic fracture-healing time was shorter (approximately 5.2 vs 5.5 months), and functional scores at final follow-up were higher (approximately 127.8 vs 123.2). PP sensitivity analyses yielded results consistent in direction with the ITT analyses, further supporting the robustness of the study conclusions.
CONCLUSION: Vibration-stimulation therapy facilitates rapid postoperative recovery in patients with lower limb fractures and has a favourable safety profile, and may represent a promising component of postoperative ERAS strategies in the future.
METHODS: This prospective randomized controlled trial consecutively screened 1,241 patients aged 18-75 years with lower limb fractures admitted to a tertiary university-affiliated orthopaedic hospital between January and December 2024, of whom 707 met the inclusion criteria. Patients were randomly assigned in a 1:1 ratio by a random number table to a vibration group or a blank control group. The primary outcomes were the seven day postoperative pain visual analogue scale (VAS) score and the incidence of lower limb deep vein thrombosis (DVT). Secondary outcomes were radiographic fracture-healing time and postoperative functional scores. The primary analysis followed the intention-to-treat (ITT) principle, comparing all randomized patients with available outcome data according to their original allocation, and a per-protocol (PP) sensitivity analysis was additionally performed.
RESULTS: A total of 707 patients completed six to 12 months of follow-up and were included in the ITT analysis (350 in the vibration group and 357 in the control group). In the overall population, the seven day postoperative incidence of lower limb DVT was significantly lower in the vibration group than in the control group [10.9% (38/350) vs 22.6% (81/357); absolute risk difference (ARD) = 11.7%]. The seven day postoperative pain scores were lower in the vibration group (weighted mean approximately 5.1 vs 5.7), radiographic fracture-healing time was shorter (approximately 5.2 vs 5.5 months), and functional scores at final follow-up were higher (approximately 127.8 vs 123.2). PP sensitivity analyses yielded results consistent in direction with the ITT analyses, further supporting the robustness of the study conclusions.
CONCLUSION: Vibration-stimulation therapy facilitates rapid postoperative recovery in patients with lower limb fractures and has a favourable safety profile, and may represent a promising component of postoperative ERAS strategies in the future.