Comparative Study of Fixation or Fusion of Calcaneal Fractures

Fracture Fixation, Internal Clinical Trial

— Sanders IV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679393
• Other study ID #: 17526
• Status: Completed
• Phase: N/A
• First received: May 14, 2008
• Last updated: February 10, 2015
• Start date: February 2004
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 59 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fracture Fixation, Internal
• Fractures, Bone
• Fractures, Comminuted
• Intra-Articular Fractures

Intervention

Procedure:
• Open reduction internal fixation
Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
• Fusion
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	AO North America, Orthopaedic Trauma Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Health Survey - SF-36		6 months, 12 months, and 24 months	No
Secondary	Validated Visual Analogue Scale		6 months, 12 months, and 24 months	No
Secondary	Musculoskeletal Function Assessment		6 months, 12 months, and 24 months	No