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Operative Versus Non Operative Treatment for Unstable Ankle Fractures
This study is currently recruiting participants.
Verified by Lawson Health Research Institute, June 2006
Sponsored by: Lawson Health Research Institute
Information provided by: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00336752
  Purpose

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:

  1. Does surgery provide a better functional outcome compared to non operative treatment of undisplaced, unstable fractures?
  2. Do patients with these fractures return to activities faster after operative or non operative treatment?
  3. Are complications more common with operative or non operative care?

Condition Intervention
Ankle Injuries
Procedure: operative versus non operative treatment

MedlinePlus related topics: Ankle Injuries and Disorders Fractures
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures

Further study details as provided by Lawson Health Research Institute:

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 64
Study Start Date: June 2003
Estimated Study Completion Date: June 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Skeletally mature male or female < 65 years of age
  2. Unstable ankle on stress exam: medial clear space ³ 5 mm: no Mortise shift on static radiographs
  3. Unilateral Weber B fibular fractures
  4. Closed fracture
  5. Provision of informed consent -

Exclusion Criteria:

  1. Fractures not amenable to surgical treatment
  2. Pathologic fracture
  3. Associated injuries to the foot, ankle, tibia, or knee
  4. Associated medial malleolus fracture
  5. Surgical delay of >2 weeks from time of injury
  6. Previous fracture or retained hardware in the affected limb
  7. Associated neurovascular injury or deficit in the affected limb
  8. Systemic diseases including diabetes, multiple sclerosis, Parkinson’s disease, and other disorders which might affect peripheral sensorimotor function -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336752

Locations
Canada, Ontario
LOndon Health Sciences cEntre- Victoria Hospital Recruiting
LOndon, Ontario, Canada, N6A 4G5
Contact: DR. DAvid Sanders, MD, FRCSC     519-685-8055        
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: DR. David Sanders, M.D., FRCSC University of Western Ontario, Canada
  More Information

Study ID Numbers: R-03-113, 09641
Study First Received: June 13, 2006
Last Updated: June 21, 2007
ClinicalTrials.gov Identifier: NCT00336752  
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
undisplaced ,unstable wEBER B ankle fractures
operative intervention
non operative intervention

Study placed in the following topic categories:
Ankle Injuries
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on January 16, 2009