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

University of Calgary4 sites in 1 country26 target enrollmentFebruary 2004

ConditionsFractures, Comminuted Fracture Fixation, Internal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Fractures, Comminuted
Sponsor: University of Calgary
Enrollment: 26
Locations: 4
Primary Endpoint: General Health Survey - SF-36
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Calgary

Responsible Party

Principal Investigator

Richard Buckley

Clinical Professor, Section of Orthopaedics, Department of Surgery

University of Calgary

Eligibility Criteria

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