Comparative Study of Fixation or Fusion of Calcaneal Fractures

University of Calgary26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fractures, Comminuted Fracture Fixation, Internal

Interventions

Open reduction internal fixationPROCEDURE

Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).

FusionPROCEDURE

Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Eligibility

Sex: ALLMin age: 16 YearsMax age: 59 Years

Medical Language ↔ Plain English

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

Locations (4)

Foothills Medical Centre

Calgary, Alberta, Canada

Halifax Infirmary, QEII Health Sciences Center

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

General Health Survey - SF-36

Time frame: 6 months, 12 months, and 24 months

Secondary Outcomes

Validated Visual Analogue Scale

Time frame: 6 months, 12 months, and 24 months

Musculoskeletal Function Assessment

Time frame: 6 months, 12 months, and 24 months

Data from ClinicalTrials.gov

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