Clinical Trial: Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial
Brief Summary: Unstable ankle fractures are commonly treated operatively. After operative reduction and fixation of the fractures, there are varying rehabilitation regimes that include non-weightbearing for 6 weeks with active range of motion exercise in a removal cast or brace, or early protected weightbearing in a rigid cast. Several papers reported that early weightbearing may decrease ankle stiffness, muscle and bone atrophy, and aids in early return to activities. However, early weightbearing may have the risk of displacement of the fixed fractures. Rehabilitation after operative treatment of an ankle fracture is still not clear. We hypothesized that the ankle function assessed on 12 months after operation of an ankle fracture with early weightbearing is not inferior to non-weightbearing but is superior to non-weightbearing with respect to time to return to normal daily life and time to full weightbearing.
Detailed Summary:
This study is a noninferiority, randomized controlled trial of patients presenting to multiple centers.
The primary outcome measure is the Olerud-Molander scores assess on 12 months after operation of an unstable ankle fracture. The Olerud-Molander scores were compared between the experimental group (early weightbearing) and the control group (non-weightbearing) on 12 month follow-up examination.
The Olerud-Molander score is a most widely used validated scale to assess ankle function after an ankle fracture. It is a self-administered patient questionnaire with a score of zero (totally impaired) to 100 (completely unimpaired) and is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living.
The secondary objectives are to determine whether early weightbearing is superior to non-weightbearing with respect to time until return to normal daily life and time to full weightbearing.
Other objectives are to determine safety by assessing number of participants with adverse effect such as hardware failure, reduction loss, non-union, or delayed union in each group.
The sample size was determined using methods appropriate for noninferiority trials, assuming 90% power and a significance level of 0.05. To find out whether the early weightbearing is not inferior to nonweightbearing after operation of an ankle fracture, 192 patients were required to have 90% power that the lower limit of an one-sided 95% confidence interval for the difference between two treatments will be above the noninferiority margin of -8, adding 20% of assumed drop-out.
Determinati
Sponsor: Hallym University Medical Center
Current Primary Outcome: The Olerud-Molander ankle function score [ Time Frame: 12 months post-operative ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Time to return to preinjury activity, time to full weightbearing, patients' subjective satisfactions, Visual analogue Scale (VAS) [ Time Frame: upto 12 months ]
Time to return to preinjury activity and time to full weightbearing is going to be assessed.
Patient's subjective satisfaction and VAS are going to be assessed on 12 months post-operative visit
Original Secondary Outcome: Same as current
Information By: Hallym University Medical Center
Dates:
Date Received: January 6, 2014
Date Started: January 2014
Date Completion: January 2017
Last Updated: October 8, 2015
Last Verified: October 2015
