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Comparative Study of Fixation or Fusion of Calcaneal Fractures (Sanders IV)

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ClinicalTrials.gov Identifier: NCT00679393
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : February 11, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Fractures, Comminuted Fracture Fixation, Internal Procedure: Open reduction internal fixation Procedure: Fusion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2004
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)
Procedure: Open reduction internal fixation
Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
Procedure: Fusion
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Outcome Measures

Primary Outcome Measures :
  1. General Health Survey - SF-36 [ Time Frame: 6 months, 12 months, and 24 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679393

Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Halifax Infirmary, QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
University of Calgary
Orthopaedic Trauma Association
AO North America
Principal Investigator: Richard E Buckley, MD University of Calgary
More Information

Responsible Party: Richard Buckley, Clinical Professor, Section of Orthopaedics, Department of Surgery, University of Calgary
ClinicalTrials.gov Identifier: NCT00679393     History of Changes
Other Study ID Numbers: 17526
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Richard Buckley, University of Calgary:
Intra-articular fracture
open reduction internal fixation
primary subtalar fusion

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Comminuted
Intra-Articular Fractures
Wounds and Injuries