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
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
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
NCT ID
NCT00679393
First Posted
May 14, 2008
Last Updated
February 10, 2015
Sponsor
University of Calgary
Collaborators
Orthopaedic Trauma Association, AO North America
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
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Comparative Study of Fixation or Fusion of Calcaneal Fractures
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