An interventional study of non operative treatment and operative treatment of ankle fractures in Ankle Injuries, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-07.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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:
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-operative treatment.A clear rationale exists for both types of treatment.
The most important factor in treatment includes maintaining the reduction of the talus within the ankle mortise. Even 1 mm of displacement or lateral shift of the talus will affect ankle joint loading and lead to dysfunction and potentially arthritis. Other issues include the potential benefits of earlier mobilization and rehabilitation.
194 studies on the registry are indexed under Ankle Fractures; 46 are open to participants now.
This study's enrollment of 80 is below the median of 93 across 147 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Non operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention
Procedure: non operative treatment
Operative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones.
Procedure: operative treatment of ankle fractures
non operative treatment -casting for 6 weeks
operative treatment of ankle fractures
Primary outcome: comparison of physical functioning score on SF36
Time frame: enrolment, 6 weeks, 3,6 12 months
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.
Number of participants with complications or adverse events that ae related to treatment
Time frame: enrolment, 6 weeks, 3,6,12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's