Comparative Study of Fixation or Fusion of Calcaneal Fractures

NCT ID: NCT00679393

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2014-12-31

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.

Conditions

Fractures, Comminuted; Fracture Fixation, Internal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fix

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

Group Type: OTHER

Open reduction internal fixation

Intervention Type: PROCEDURE

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

Fuse

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

Group Type: OTHER

Fusion

Intervention Type: PROCEDURE

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

Interventions

Open reduction internal fixation

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

Intervention Type: PROCEDURE

Fusion

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Trauma Association

OTHER

Sponsor Role: collaborator

AO North America

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Richard Buckley

Clinical Professor, Section of Orthopaedics, Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard E Buckley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Halifax Infirmary, QEII Health Sciences Center

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

17526

Identifier Type: -

Identifier Source: org_study_id