Status:

UNKNOWN

A Prospective Randomized Pilot Study to Compare Open Versus Percutaneous Syndesmosis Repair of Unstable Ankle Fractures

Lead Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Conditions:

Fracture Dislocation of Ankle Joint

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study evaluates fracture healing, anatomic reduction and return to functioning in patients with unstable Weber C type fractures of the ankle. Best outcomes are obtained when a good alignment of t...

Detailed Description

High ankle fractures involve fracture of the fibula above the level of the syndesmosis (space between the tibia and fibula bones) that result from indirect mechanisms (e.g. pronation-external rotation...

Eligibility Criteria

Inclusion

  • The subject is 18 years old or greater with a pre-operative diagnosis of a Weber C ankle fracture (supination-external rotation, pronation-external rotation, pronation-abduction patterns).
  • The subject demonstrates lateral subluxation of the talus on x-ray or stress views (unstability).
  • The lateral malleolus fracture if present begins at least 1.0 cm proximal to the syndesmosis.
  • The subject has no history of previous ankle injury.
  • The subject does not have an ipsilateral lower extremity injury that would impede results.
  • The subject has no neuromuscular or neurosensory deficiency that would limit the ability to assess the operative procedure.
  • \-

Exclusion

  • The subject has a lateral malleolus fracture that begins less than 1.0 cm proximal to the syndesmosis.
  • The subject has an open ankle fracture with a lateral wound. -

Key Trial Info

Start Date :

August 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2020

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT02245893

Start Date

August 1 2013

End Date

June 1 2020

Last Update

February 26 2019

Active Locations (1)

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1

London Health Sciences Centre

London, Ontario, Canada, N6A4G5