Operative Versus Non Operative Treatment for Unstable Ankle Fractures

NCT ID: NCT00336752

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-08-31

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:

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?

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.

Conditions

Ankle Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Non operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention

Group Type: ACTIVE_COMPARATOR

non operative treatment

Intervention Type: PROCEDURE

non operative treatment -casting for 6 weeks

2

Operative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones.

Group Type: ACTIVE_COMPARATOR

operative treatment of ankle fractures

Intervention Type: PROCEDURE

operative treatment of ankle fractures

Interventions

non operative treatment

non operative treatment -casting for 6 weeks

Intervention Type: PROCEDURE

operative treatment of ankle fractures

operative treatment of ankle fractures

Intervention Type: PROCEDURE

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

David Sanders

Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DR. David Sanders, M.D., FRCSC

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

LOndon Health Sciences cEntre- Victoria Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

HSREB09641

Identifier Type: OTHER

Identifier Source: secondary_id

R-03-113

Identifier Type: -

Identifier Source: org_study_id