Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336752
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2006-06-13
Brief Title:
Operative Versus Non Operative Treatment for Unstable Ankle Fractures
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 injuriesPrevious 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 surgicallyTherefore 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 treatmentA 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
In North America most surgeons would agree that markedly unstable definitely unstable ankle fractures are best treated surgicallyTherefore 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 treatmentA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSREB09641 | OTHER | Western University Research Ethics | None |