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Operative Versus Non Operative Treatment for Unstable Ankle Fractures

NCT00336752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-07

No results posted yet for this study

Summary

The purpose of the study is to compare functional outcomes and recovery following surgical and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary objectives are to compare the re-operation rate, time to union and complications between the two treatment groups.

The primary research questions:

1. Does surgery provide a better functional outcome compared to non operative treatment of undisplaced, unstable fractures?
2. Do patients with these fractures return to activities faster after operative or non operative treatment?
3. Are complications more common with operative or non operative care?

Conditions

  • Ankle Injuries

Interventions

PROCEDURE

non operative treatment

non operative treatment -casting for 6 weeks

PROCEDURE

operative treatment of ankle fractures

operative treatment of ankle fractures

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • DR. David Sanders, M.D., FRCSC · Western University, Canada

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
2003-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT00336752 on ClinicalTrials.gov