Clinical Trial: Combined Randomised and Observational Study of Surgery for Type B Ankle Fracture Treatment

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Combined Randomised and Observational Study of Surgery for Type B Ankle Fracture Treatment

Brief Summary: This study will determine whether operative management confers improved short and long−term outcomes for patients with isolated AO type 44−B1 distal fibula fractures when compared with non−operative management.

Detailed Summary:

Background:

Ankle fractures are common. Recent clinical studies have shown that there is an increasing incidence of ankle fractures. Treatments vary and there is no clear consensus of the ideal approach to type 44−B1 distal fibular fractures. They range from open reduction and internal fixation to restore anatomical alignment to wearing below−knee walking plaster for an average of six weeks.

The argument for surgical fixation is that it addresses minor displacement and possible future displacement therefore potentially preventing future arthritis. On the other hand, there are numerous complications associated with surgery.

The argument for non−operative treatment is that non−union is not a common complication. Therefore surgery can be avoided in the majority of cases avoiding the clinical risks associated with surgery.

Aim:

Primary aim: To compare, ankle function and quality of life 5 years following an isolated AO type 44−B1 distal fibula fracture minimal talar shift, between patients treated operatively and non−operatively.

Research Design: Combined Randomised and Observational Study

Methods:

Recruitment:

All consecutive patients who present to a recruiting hospital with a distal fibular fracture during the study period will be screened for eligibility. In most hospitals, all surgeons on the on-call roster will participate in the study. Consenting patients of the surgeons who have agreed to participate in the randomised arm of the trial will
Sponsor: The University of New South Wales

Current Primary Outcome:

• American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire [ Time Frame: 5 years ]
  American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire
• PCS of Short Form (SF)-12v2 [ Time Frame: 5 years ]
  SF-12 version 2 Health Survey

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complications [ Time Frame: 5 years ]
  Late surgery Infection Neurovascular complication Mortality
• MCS of Short Form (SF)-12v2 [ Time Frame: 5 years ]
  SF-12 version 2 Health Survey

Original Secondary Outcome: Same as current

Information By: The University of New South Wales

Dates:
Date Received: March 12, 2017
Date Started: August 2010
Date Completion: December 2019
Last Updated: March 12, 2017
Last Verified: March 2017