Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture

October 8, 2015 updated by: Hyong Nyun Kim, Hallym University Medical Center

Early Weightbearing Versus Non-weightbearing After Operative Treatment of an Ankle Fracture: A Randomized Multicenter Non-inferiority Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Determination of the noninferiority margin was based on clinical significance. In a previous study between early weightbearing versus nonweightbearing after an ankle fracture surgery, Simanski et al. reported that both groups showed good results in the Olerud-Molander score (87 vs. 79 points; p=0.25). In both groups, the majority of patients reached their preinjury level of activity. The difference in the Olerud-Molander score between the two groups was 8 points in favor of early weightbearing. Their study came from populations similar to our trial population and from interventions similar to those being studied in the current trial. We decided that the noninferiority margin at 8 points difference will be adequate to prove noninferiority of the experiment group (early weightbearing) over the control group (nonweightbearing).

If a subject had discontinued prior to completion of 12 months, the last observation is carried forward for the intent-to-treat analysis. Subjects who crossed over to the other treatment arm, for an example, patients in non-weightbearing group who weightbear early, are analyzed according to their initial group allocation for the intent-to-treat analysis. Additionally, an as-treated (per-protocal) analysis was also conducted on patients who completed the 12 months follow-up with the protocol assigned.

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-950
        • Recruiting
        • Kangnam Sacred Heart Hospital, Hallym University College of Medicine
        • Contact:
        • Principal Investigator:
          • Hyong Nyun Kim, MD, PhD
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
        • Recruiting
        • Hallym University Sacred Heart Hospital, Hallym University College of Medicine
        • Contact:
        • Principal Investigator:
          • Jae Yong Park, MD
    • Gyeongi
      • Gunpo, Gyeongi, Korea, Republic of, 435-040
        • Recruiting
        • Sanbon Hospital, Wonkwang University College of Medicine
        • Contact:
        • Principal Investigator:
          • Yu Mi Kim, MD, PhD
      • Seongnam, Gyeongi, Korea, Republic of, 463-712
        • Recruiting
        • CHA Bundang Medical Center, CHA University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unstable ankle fracture requiring open reduction and internal fixation
  • age between 18 and 65 years
  • satisfactory reduction and stable fixation after operation.

Exclusion Criteria:

  • open fractures
  • comminuted fractures
  • pathologic fractures
  • Pilon fractures
  • Trimalleolar fractures
  • fracture dislocations
  • Fractures requiring syndesmotic screw fixation
  • Fractures with cartilage injuries or unstable fixation or any other conditions preventing from early weightbearing.
  • Patients with diabetes or neuroarthropathy
  • Patients with obesity (BMI >30, weight >100 kg)
  • Any other conditions that are expected to prevent the patients from following the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early weightbearing
After operative reduction and fixation of the fractures, patients allocated to the early weightbearing group start weightbearing after stitch out at 2 weeks and the application of a walking cast.
Procedure: Early weightbearing
Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast
Active Comparator: Non-weightbearing
Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative
Procedure: Non-weightbearing
Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Olerud-Molander ankle function score
Time Frame: 12 months post-operative
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.
12 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
upto 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with hardware failure, reduction loss, delayed union or non-union are assessed
Time Frame: Up to 12 month
A reduction loss or hardware failure was defined as one that occurred without patient instigation of inappropriate activity. The reduction loss or metal failure rate was to be monitored by study personnel not involved in the outcome assessment. >2 mm displacement. Delayed union was defined as a lack of bridging callus on 3 of 5 cortices at 12 weeks. Nonunion was defined as lack of cortical bridging or a clearly visible fracture line, at 14 weeks post injury.
Up to 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Medical Center

Investigators

  • Study Chair: Hyong Nyun Kim, MD, PhD, Kangnam Sacred Heart Hospital, Hallym University College of Medicine
  • Study Director: Hyong Nyun Kim, MD, PhD, Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUKSHHOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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