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OpenTrials
Completed

NCT Number: NCT00679393

Comparative Study of Fixation or Fusion of Calcaneal Fractures

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.

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Key information

Conditions

Fractures, Comminuted Fracture Fixation, Internal Fractures, Bone Intra-Articular Fractures Wounds and Injuries

Age range

16 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open reduction internal fixation

Procedure

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

Fusion

Procedure

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

Primary outcomes

  1. General Health Survey - SF-36

    Time frame: 6 months, 12 months, and 24 months

Secondary outcomes

  1. Validated Visual Analogue Scale

    Time frame: 6 months, 12 months, and 24 months

  2. Musculoskeletal Function Assessment

    Time frame: 6 months, 12 months, and 24 months

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • AO North America
  • Orthopaedic Trauma Association

Registry information

Official study 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

Acronym: Sanders IV

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
May 16, 2008
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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