The effects of early weight-bearing and mobilization on the outcomes of patients with unstable ankle fractures after internal fixation surgery

Evaluation of the effect of early weight-bearing and mobilization following internal fixation surgery of unstable ankle fractures

Clinical trial with control group, with parallel groups, not blinded, randomized, phase 3 on 50 patients

A total of 50 patients with unstable ankle fracture referred to Shahid Beheshti Hospital in Kashan will be included in this clinical trial. After measuring anthropometric indices, they will be randomly allocated to early weight-bearing/mobilization group or control group and outcomes will be evaluated 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

Inclusion criteria: Patients who aged 18-65 Years, Unstable fractures of lateral malleolus with or without talar shift, Unstable fractures of medial malleolus or vertical fractures of the medial malleolus, Bimalleolar fractures, Trimalleolar fractures (fractures involved less than 25% of posterior malleolus and do not require posterior malleolus surgery), Closed fractures and open fractures of grade 1 and 2. Exclusion criteria: Immature skeleton, Previous ankle surgery, The need for medical care preventing other practical interventions, Impossibility to follow the protocol after the operation, Surgery after more than 14 days from the time of injury, Concurrent posterior malleolus fracture with more than 25% involvement, Grade 3 open fractures, Concurrent Syndesmosis Injury

Intervention group: Weight-bearing and mobilization will begin 2 weeks after internal fixation surgery of unstable ankle fractures (n = 25) Control group: Weight-bearing and mobilization will begin 6 weeks after internal fixation surgery of unstable ankle fractures (n = 25)

Time required to return to work, Time required to bear full body weight, Olerud-Molander Ankle Score, Number of required physiotherapy sessions

First, the intervention group (early weight-bearing) was coded with the letter A and the control group with the letter B, and then using the website www. sealedenvelope.com/simple-randomiser/v1/lists, randomization list was prepared by selecting a sample size of 52 (two groups of 26) and permuted block randomization method (block size=4) (13 blocks of 4). Then, through the obtained randomization list, the subjects included in the study will be assigned to one of the two groups A or B (Based on the entry order). For example, suppose that in the first four blocks, the permutation method is ABBA, so the first and fourth samples will be assigned to group A and the second and third samples to group B and the same will continue until the last sample (52th person).