Early Weightbearing Versus Nonweightbearing After Operative Treatment of an Ankle Fracture: A Multicenter, Noninferiority, Randomized Controlled Trial  

SLR - February 2022 - Aaron M. Medina

Reference: Park JY, Kim BS, Kim YM, Cho JH, Choi YR, Kim HN. Early Weightbearing Versus Nonweightbearing After Operative Treatment of an Ankle Fracture: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Sports Med. 2021 Aug;49(10) 

Level of Evidence: I

Scientific Literature Review 

Reviewed By: Aaron M. Medina, DPM
Residency Program: Kaiser San Francisco Bay Area Foot & Ankle  Residency Program – Oakland, CA 

Podiatric Relevance: Ankle fractures are one of the most common injuries in sporting activity with unstable ankle fractures typically undergoing open reduction internal fixation (ORIF). There are varying beliefs in the weight bearing (WB) status after ORIF with approximately six weeks being the recognized time for bone healing sufficient to sustain WB. Recent literature has begun to show that early WB at two weeks post operatively is safe and aids in sooner return to activity.  This study is unique in further evaluating early WB with a noninferiority randomized controlled trial in a multicenter hospital system. 

Methods: This is a Multicenter, noninferiority, randomized controlled trial in a six hospital system. Unstable ankle fractures that underwent ORIF were prospectively randomized into two groups: early WB or non WB at two weeks post operatively. Ankle fractures that were included were unimalleolar, bimalleolar but trimalleolar ankle fractures were excluded. Randomization occurred after two weeks when the incision had healed. The early WB group was allowed to start WB at two weeks in a walking boot. The non WB group stated ankle range of motion (ROM) at two weeks in removable boot but were kept NWB for six week. After six weeks both groups were encouraged to begin active activity. 

The primary outcome is a comparison between the Olerud-Molander ankle score at 12 months. Assessments were performed at six, eight, and 12 weeks. The secondary outcomes measured were return to prior activities and patients subjective satisfactions. Complications were also taken into account including hardware loosening or failure, fracture displacement, and nonunion. 

Results: The lower limit of the CI exceeded the noninferiority margin which supports that early WB is not inferior to non WB. There was no statistically significant difference in the satisfaction between the groups however the early WB returned to their pre injury activities sooner than the non WB group. 

Conclusions: Early WB in unstable unimalleolar and bimalleolar ankle fractures fixed with ORIF is not inferior to non WB and may allow for shorter duration of return to pre injury activity level.