CompletedNot Applicable

Comparative Study of Fixation or Fusion of Calcaneal Fractures

Canada26 participantsStarted 2004-02

Plain-language 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.

Who can participate

Age range16 Years – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

General Health Survey - SF-36

Timeframe: 6 months, 12 months, and 24 months

Trial details

NCT IDNCT00679393

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12