Comparative Study of Fixation or Fusion of Calcaneal Fractures - Full Text View

Sponsors and Collaborators:	University of Calgary Orthopaedic Trauma Association AO North America
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00679393

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

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

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 2011
Estimated Primary Completion Date:	December 2009 (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

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

Contacts

Contact: Kimberly Carcary, MSc

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
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: David Stephen, MD
London Health Sciences Centre	Recruiting
London, Ontario, Canada
Principal Investigator: David Sanders, 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

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

Keywords provided by University of Calgary:

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

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fractures, Comminuted

ClinicalTrials.gov processed this record on January 15, 2009