NCT00679393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

10.8 years

First QC Date

May 14, 2008

Last Update Submit

February 10, 2015

Conditions

Fractures, ComminutedFracture Fixation, Internal

Keywords

CalcaneusIntra-articular fractureopen reduction internal fixationprimary subtalar fusion

Outcome Measures

Primary Outcomes (1)

  • General Health Survey - SF-36

    6 months, 12 months, and 24 months

Secondary Outcomes (2)

  • Validated Visual Analogue Scale

    6 months, 12 months, and 24 months

  • Musculoskeletal Function Assessment

    6 months, 12 months, and 24 months

Study Arms (2)

Fix

OTHER

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

Procedure: Open reduction internal fixation

Fuse

OTHER

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

Procedure: Fusion

Interventions

Open reduction internal fixationPROCEDURE

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

Fix
FusionPROCEDURE

Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)

Fuse

Eligibility Criteria

Age16 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Halifax Infirmary, QEII Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Fractures, ComminutedIntra-Articular Fractures

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Richard E Buckley, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Section of Orthopaedics, Department of Surgery

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

February 1, 2004

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

CA(4)