Operative Versus Non Operative Treatment for Unstable Ankle Fractures

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00336752
First received: June 13, 2006
Last updated: June 29, 2011
Last verified: June 2011
  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: non operative treatment
Procedure: operative versus non operative treatment of ankle fractures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Primary outcome: comparison of physical functioning score on SF36 [ Time Frame: enrolment, 6 weeks, 3,6 12 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: enrolment, 6 weeks, 3,6,12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: June 2003
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Non operative treatment of Weber B ankle fracture
Procedure: non operative treatment
non operative treatment -casting for 6 weeks
Active Comparator: 2
Operative treatment of Weber B ankle fracture
Procedure: operative versus non operative treatment of ankle fractures
operative versus non operative treatment of ankle fractures

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336752

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

No publications provided

Responsible Party: Dr. David Sanders, LHRI
ClinicalTrials.gov Identifier: NCT00336752     History of Changes
Other Study ID Numbers: R-03-113, 09641
Study First Received: June 13, 2006
Last Updated: June 29, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Fractures, Bone
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 26, 2014