Status:
COMPLETED
Comparative Study of Fixation or Fusion of Calcaneal Fractures
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Orthopaedic Trauma Association
AO North America
Conditions:
Fractures, Comminuted
Fracture Fixation, Internal
Eligibility:
All Genders
16-59 years
Phase:
NA
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 calcanea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00679393
Start Date
February 1 2004
End Date
December 1 2014
Last Update
February 11 2015
Active Locations (4)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
Halifax Infirmary, QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
3
London Health Sciences Centre
London, Ontario, Canada
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5