Clinical Trial: Operative Versus Non Operative Treatment for Unstable Ankle Fractures
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures
Brief Summary:
The purpose of the study is to compare functional outcomes and recovery following surgical and non surgical treatment of potentially unstable , isolated fibula fractures. Secondary objectives are to compare the re-operation rate, time to union and complications between the two treatment groups.
The primary research questions:
- Does surgery provide a better functional outcome compared to non operative treatment of undisplaced, unstable fractures?
- Do patients with these fractures return to activities faster after operative or non operative treatment?
- Are complications more common with operative or non operative care?
Detailed Summary:
The most controversial ankle fracture is the Weber B fracture in which the fibular (or lateral malleolar) fracture begins at the level of the ankle mortise and extends proximal and lateral. This fracture can exist as isolated fractures of the lateral malleolus, or bimalleolar injuries in which both lateral and medial malleoli are fractured. When both malleoli are fractured, the ankle has lost all of its bony support and is unstable. In contrast, if only the lateral malleolus is injured, the Weber B injury may be either stable or unstable. When the ankle is subluxed or dislocated in these injuries, the ankle is clearly unstable. However, when the ankle is not initially subluxed, the assessment of stability is more difficult. Stability in isolated lateral malleolar fractures depends upon the status of the medial, or deltoid, ligaments. Further complicating matters, the deltoid ligament may be intact, partially torn, or completely torn such that there is a spectrum of stability for these injuries.Previous studies relied upon an assessment of tenderness over the ligament to determine instability, but this may not differentiate between partial and complete tears.
In North America, most surgeons would agree that markedly unstable definitely unstable ankle fractures are best treated surgically.Therefore, Weber B fractures which involve fractures of both the medial and lateral malleolus are best treated by surgical stabilization. Furthermore, Weber B fractures involving only the lateral malleolus, but which present with lateral subluxation of the talus, are definitely unstable and require fixation.
In contrast, controversy exists between surgeons regarding the optimal means of treating an undisplaced but potentially unstable fibula fracture. Many surgeons recommend routine operative fixation, while others recommend routine non-ope
Sponsor: Lawson Health Research Institute
Current Primary Outcome: Primary outcome: comparison of physical functioning score on SF36 [ Time Frame: enrolment, 6 weeks, 3,6 12 months ]
Original Primary Outcome: Comparison of functional outcomes following surgical and non-surgical treatment at routine follow up vists through clinical assessment and quality of life questionnaires.
Current Secondary Outcome: Secondary objectives are to compare the re-operation rate between operative and non-operative treatment and to compare the time to union, rates of nonunion and complications such as infection between the two groups. [ Time Frame: enrolment, 6 weeks, 3,6,12 months ]
Original Secondary Outcome: Secondary objectives are to compare the re-operation rate between operative and non-operative treatment and to compare the time to union, rates of nonunion and complications such as infection between the two groups.
Information By: Lawson Health Research Institute
Dates:
Date Received: June 13, 2006
Date Started: June 2003
Date Completion:
Last Updated: September 6, 2016
Last Verified: September 2016
