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CompletedNCT00679393Sanders IVUpdated Feb 11, 2015

Comparative Study of Fixation or Fusion of Calcaneal Fractures

An interventional study of Open reduction internal fixation and Fusion in Fractures, Comminuted and Fracture Fixation, Internal, sponsored by University of Calgary. Completed at 4 sites in Canada. Open to participants aged 16 Years to 59 Years. Per ClinicalTrials.gov, last updated 2015-02-11.

Sponsored by University of Calgary · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
16 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fractures, Comminuted
  • Fracture Fixation, Internal

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Keywords

  • Calcaneus
  • Intra-articular fracture
  • open reduction internal fixation
  • primary subtalar fusion
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 26 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Other
    Fix

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

    Procedure: Open reduction internal fixation

  • Other
    Fuse

    Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).

    Procedure: Fusion

Interventions

  • ProcedureOpen reduction internal fixation

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

  • ProcedureFusion

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

06

What researchers measure

Primary outcomes

  1. General Health Survey - SF-36

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

Secondary outcomes

  1. Validated Visual Analogue Scale

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

  2. Musculoskeletal Function Assessment

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

07

Study locations

4 sites
  • Foothills Medical Centre
    Calgary, Alberta T2N 2T9, Canada
  • Halifax Infirmary, QEII Health Sciences Center
    Halifax, Nova Scotia B3H 3A7, Canada
  • London Health Sciences Centre
    London, Ontario, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00679393
Lead sponsor
University of Calgary
Collaborators
Orthopaedic Trauma Association, AO North America
Responsible party
Richard Buckley (Clinical Professor, Section of Orthopaedics, Department of Surgery, University of Calgary) — Principal investigator
First posted
May 16, 2008
Start date
Feb 2004
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 11, 2015

Study contacts

Richard E Buckley, MD
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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