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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Orthopaedic Trauma Association
AO North America
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00679393
First received: May 14, 2008
Last updated: May 10, 2010
Last verified: May 2010
  Purpose

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 Intervention
Fractures, Comminuted
Fracture Fixation, Internal
Procedure: Open reduction internal fixation
Procedure: Fusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • General Health Survey - SF-36 [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validated Visual Analogue Scale [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
  • Musculoskeletal Function Assessment [ Time Frame: 6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2004
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fix
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).
Fuse
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
Procedure: Fusion
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

  Eligibility

Ages Eligible for Study:   16 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679393

Contacts
Contact: Kimberly Carcary, MSc, CCRP 403-944-2932 kdcarcar@ucalgary.ca

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

No publications provided

Responsible Party: Dr. Richard E. Buckley, University of Calgary
ClinicalTrials.gov Identifier: NCT00679393     History of Changes
Other Study ID Numbers: 17526
Study First Received: May 14, 2008
Last Updated: May 10, 2010
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 27, 2014