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

Primary Purpose

Fractures, Comminuted, Fracture Fixation, Internal

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Open reduction internal fixation
Fusion
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractures, Comminuted focused on measuring Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion

Eligibility Criteria

16 Years - 59 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Foothills Medical Centre
  • Halifax Infirmary, QEII Health Sciences Center
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Fix

Fuse

Arm Description

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

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

Outcomes

Primary Outcome Measures

General Health Survey - SF-36

Secondary Outcome Measures

Validated Visual Analogue Scale
Musculoskeletal Function Assessment

Full Information

First Posted
May 14, 2008
Last Updated
February 10, 2015
Sponsor
University of Calgary
Collaborators
Orthopaedic Trauma Association, AO North America
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1. Study Identification

Unique Protocol Identification Number
NCT00679393
Brief Title
Comparative Study of Fixation or Fusion of Calcaneal Fractures
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Orthopaedic Trauma Association, AO North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Comminuted, Fracture Fixation, Internal
Keywords
Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fix
Arm Type
Other
Arm Description
Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV)
Arm Title
Fuse
Arm Type
Other
Arm Description
Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV).
Intervention Type
Procedure
Intervention Name(s)
Open reduction internal fixation
Intervention Description
Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).
Intervention Type
Procedure
Intervention Name(s)
Fusion
Intervention Description
Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)
Primary Outcome Measure Information:
Title
General Health Survey - SF-36
Time Frame
6 months, 12 months, and 24 months
Secondary Outcome Measure Information:
Title
Validated Visual Analogue Scale
Time Frame
6 months, 12 months, and 24 months
Title
Musculoskeletal Function Assessment
Time Frame
6 months, 12 months, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Buckley, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Halifax Infirmary, QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Fixation or Fusion of Calcaneal Fractures

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