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

University of Calgary

Status: Completed

Conditions: Fractures, Comminuted; Fracture Fixation, Internal

Treatments: Procedure: Open reduction internal fixation; Procedure: Fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00679393

17526

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 16 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Fix

Other group

Description:

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

Treatment:

Procedure: Open reduction internal fixation

Fuse

Other group

Description:

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

Treatment:

Procedure: Fusion