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Immediate Weight-Bearing Ankle Study

NCT03032653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-04-23

No results posted yet for this study

Summary

This single-centre historical control group comparative study will compare outcomes of surgically-treated rotational ankle fractures and the current routine practice of early protected weightbearing and range of motion with immediate unprotected weightbearing as tolerated and range of motion after ankle open reduction and internal fixation.

Conditions

  • Ankle Fractures
  • Surgery

Interventions

OTHER

Late Rehabilitation

Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot. 6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:

OTHER

Early Rehabilitation

Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted

Sponsors & Collaborators

  • Fraser Orthopaedic Research Society

    lead NETWORK

Principal Investigators

  • Darius G Viskontas, MD, FRCSC · Royal Columbian Hospital / Fraser Health Authority

  • Vu (Brian) Le, MD, FRSCS · Royal Columbian Hospital / Fraser Health Authority

  • Kelly L Apostle, MD, FRCSC · Royal Columbian Hospital / Fraser Health Authority

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2021-01-18
Completion
2021-01-18

Countries

  • Canada

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 NCT03032653 on ClinicalTrials.gov