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

NCT02029170 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2015-10-09

No results posted yet for this study

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.

Conditions

  • Ankle Fracture
  • Rehabilitation

Interventions

PROCEDURE

Early weightbearing

Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast

PROCEDURE

Non-weightbearing

Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative

Sponsors & Collaborators

  • Hallym University Medical Center

    lead OTHER

Principal Investigators

  • Hyong Nyun Kim, MD, PhD · Kangnam Sacred Heart Hospital, Hallym University College of Medicine

  • Hyong Nyun Kim, MD, PhD · Kangnam Sacred Heart Hospital, Hallym University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029170 on ClinicalTrials.gov