Comparative Study of Fixation or Fusion of Calcaneal Fractures

Not Applicable

Completed

• Conditions: Fracture Fixation, Internal; Fractures, Comminuted
• Interventions: Procedure: Open reduction internal fixation; Procedure: Fusion

• Registration Number: NCT00679393
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fix	Open reduction internal fixation	Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)
Fuse	Fusion	Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).

Primary Outcome Measures

Name	Time	Method
General Health Survey - SF-36	6 months, 12 months, and 24 months

Secondary Outcome Measures

Name	Time	Method
Validated Visual Analogue Scale	6 months, 12 months, and 24 months
Musculoskeletal Function Assessment	6 months, 12 months, and 24 months

Trial Locations

Locations (4)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Halifax Infirmary, QEII Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada