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Operative Versus Non Operative Treatment for Unstable Ankle Fractures

Primary Purpose

Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
non operative treatment
operative treatment of ankle fractures
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring undisplaced ,unstable wEBER B ankle fractures, operative intervention, non operative intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Skeletally mature male or female < 65 years of age Unstable ankle on stress exam: medial clear space ³ 5 mm: no Mortise shift on static radiographs Unilateral Weber B fibular fractures Closed fracture Provision of informed consent - Exclusion Criteria: Fractures not amenable to surgical treatment Pathologic fracture Associated injuries to the foot, ankle, tibia, or knee Associated medial malleolus fracture Surgical delay of >2 weeks from time of injury Previous fracture or retained hardware in the affected limb Associated neurovascular injury or deficit in the affected limb Systemic diseases including diabetes, multiple sclerosis, Parkinson's disease, and other disorders which might affect peripheral sensorimotor function -

Sites / Locations

  • LOndon Health Sciences cEntre- Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Primary outcome: comparison of physical functioning score on SF36

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.
Number of participants with complications or adverse events that ae related to treatment

Full Information

First Posted
June 13, 2006
Last Updated
September 6, 2016
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00336752
Brief Title
Operative Versus Non Operative Treatment for Unstable Ankle Fractures
Official Title
A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
undisplaced ,unstable wEBER B ankle fractures, operative intervention, non operative intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Non operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Operative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones.
Intervention Type
Procedure
Intervention Name(s)
non operative treatment
Intervention Description
non operative treatment -casting for 6 weeks
Intervention Type
Procedure
Intervention Name(s)
operative treatment of ankle fractures
Intervention Description
operative treatment of ankle fractures
Primary Outcome Measure Information:
Title
Primary outcome: comparison of physical functioning score on SF36
Time Frame
enrolment, 6 weeks, 3,6 12 months
Secondary Outcome Measure Information:
Title
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.
Description
Number of participants with complications or adverse events that ae related to treatment
Time Frame
enrolment, 6 weeks, 3,6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletally mature male or female < 65 years of age Unstable ankle on stress exam: medial clear space ³ 5 mm: no Mortise shift on static radiographs Unilateral Weber B fibular fractures Closed fracture Provision of informed consent - Exclusion Criteria: Fractures not amenable to surgical treatment Pathologic fracture Associated injuries to the foot, ankle, tibia, or knee Associated medial malleolus fracture Surgical delay of >2 weeks from time of injury Previous fracture or retained hardware in the affected limb Associated neurovascular injury or deficit in the affected limb Systemic diseases including diabetes, multiple sclerosis, Parkinson's disease, and other disorders which might affect peripheral sensorimotor function -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR. David Sanders, M.D., FRCSC
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
LOndon Health Sciences cEntre- Victoria Hospital
City
LOndon
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Operative Versus Non Operative Treatment for Unstable Ankle Fractures

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