Comparative Study of Fixation or Fusion of Calcaneal Fractures (Sanders IV)

February 10, 2015 updated by: Richard Buckley, University of Calgary

A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus

A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Halifax Infirmary, QEII Health Sciences Center
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

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

16 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with Sanders IV displaced intra-articular calcaneal fracture
  • males and females aged 16-59 inclusive
  • ability to provide informed consent
  • available for follow-up for at least 2 years after injury

Exclusion Criteria:

  • medical contraindications to surgery
  • previous calcaneal pathology (infection, tumor, etc)
  • co-existent foot or ipsilateral lower limb injury
  • open calcaneal fracture
  • injury greater than 3 weeks old
  • head injured patients
  • inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system
  • inability to comply with advice to diminish smoking after the injury
  • metal allergy
  • extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon
  • any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

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
Other: Fix
Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)
Procedure: Open reduction internal fixation
Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
Other: Fuse
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
Procedure: Fusion
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General Health Survey - SF-36
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Validated Visual Analogue Scale
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months
Musculoskeletal Function Assessment
Time Frame: 6 months, 12 months, and 24 months
6 months, 12 months, and 24 months

Collaborators and Investigators

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

Sponsor

University of Calgary

Collaborators

Orthopaedic Trauma Association
AO North America

Investigators

  • Principal Investigator: Richard E Buckley, MD, University of Calgary

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

February 1, 2004

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 14, 2008

First Posted (Estimate)

May 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17526

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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