Aftertreatment of malleolar fractures following ORIF—functional compared to protected functional in a vacuum-stabilized orthesis: a randomized controlled trial

Abstract

In a monocenter randomized controlled trial, 45 patients with isolated malleolar fracture type OTA/AO 44 A1-B2 undergoing ORIF were allocated randomly to a postoperative treatment either with a vacuum-stabilized orthesis with prescribed full weight bearing after the second week (23 patients) (orthesis group -- OG) or with functional aftertreatment with partial weight bearing of 15 kg for 6 weeks (22 patients) (control group -- CG). Outcomes were compared at 6- and 10-week follow-up examinations. The Olerud and Molander ankle (OMA) score, ankle swelling, usage of crutches, range of motion, Short Form 12, patient-reported visual analogue scales (VAS) (pain, comfort, walking confidence) and time to return to work were evaluated. All patients of OG showed reduced swelling at discharge. The median OMA scores after 6 weeks were 42 and 42.5 (p = 0.46) and after 10 weeks 69 and 72 (p = 0.55) in the OG and CG, respectively. The time to achieve secure walking capacity was reduced by 1 day (p = 0.03) in the OG. After ORIF of simple malleolar fractures, patients with a vacuum-stabilized orthesis can bear full weight 2 weeks postoperatively. This group experienced no adverse events. Postoperative swelling was significantly reduced and of the ability to walk on stairs confidently was shorter as compared to a functional aftertreatment without any external stabilization of the ankle.

Weight-Bearing and Mobilization in the Postoperative Care of Ankle Fractures: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Cohort Studies

“…In 11 (44%) studies, a high risk of other bias was found. In 7 of these studies, patients with a Weber A fracture who had undergone surgery were included [ 13 , 27 , 33 , 36 , 38 , 39 , 43 ]. However, further specifications of these fractures were not presented.…”

“…A total of 19 studies investigated the effect of mobilization (ankle exercises) on recovery [ 13 , 27 – 33 , 35 – 38 , 40 – 46 ]. Honigmann et al and Laarhoven van et al only reported the median results and Wetzler et al did not describe enough data for analysis [ 36 , 37 , 46 ]. Therefore, these three studies were excluded from the analysis.…”

A study on surgical treatment of ankle fractures- A clinical study of 21 cases

“…1 They are usually mixed injuries, ligamentous and bony and each injury is an end result of the sequence of ligamentous and bony failure due to deforming forces. 2 Malleolar fracture have varied presentations which have given rise to a wide variety of classification systems, of which two are Lauge -Hansens and Danis -Weber classification.…”

Clinical research on postoperative trauma care: has the position of observational studies changed?

“…Two articles had one or more authors that were affiliated with a research department [11, 18]. Both were RCTs and had a relative high score on the Cochrane risk of bias assessment tool and the MINORS criteria.…”