Ankle InjuriesNCT00336752
Operative Versus Non Operative Treatment for Unstable Ankle Fractures
A study testing non operative treatment and operative treatment of ankle fractures in people with Ankle Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- non operative treatment and operative treatment of ankle fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Canada1 site
LOndon Health Sciences cEntre- Victoria Hospital
London, Ontario, N6A 4G5
About this study
Official title: A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures
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?
Read the 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
- Being tested
- non operative treatment, operative treatment of ankle fractures
- Keywords
- undisplaced ,unstable wEBER B ankle fractures, operative intervention, non operative intervention
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non operative treatmentProcedure or surgery
non operative treatment -casting for 6 weeks
operative treatment of ankle fracturesProcedure or surgery
operative treatment of ankle fractures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Non operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention Receives: Procedure: non operative treatment |
| 2 | Active comparator | Operative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones. Receives: Procedure: operative treatment of ankle fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: comparison of physical functioning score on SF36
Measured: enrolment, 6 weeks, 3,6 12 months
Secondary outcomes (1)
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
Measured: enrolment, 6 weeks, 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startJun 2003
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Sanders, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- DR. David Sanders, M.D., FRCSC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336752
- Sponsor's protocol ID
- R-03-113
- Other IDs
- HSREB09641
- Status last verified
- Sep 2016
- First submitted
- 13 Jun 2006
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multi-Centre Study to Compare Operative Versus Non Operative Functional Treatment in Patients With Unstable Isolated Fibula Fractures
- ClinicalTrials.gov ID
- NCT00336752
- Acronym / sponsor ID
- R-03-113
- Conditions
- Ankle Injuries
- Keywords
- undisplaced ,unstable wEBER B ankle fractures, operative intervention, non operative intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: non operative treatmentNon operative treatment of Weber B ankle fracture. Use of cast, with no surgical intervention |
| 2 | Active comparator | Procedure: operative treatment of ankle fracturesOperative treatment of Weber B ankle fracture. Open reduction and internal fixation to repair a broken bones. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non operative treatmentnon operative treatment -casting for 6 weeks | Procedure or surgery | 1 |
| operative treatment of ankle fracturesoperative treatment of ankle fractures | Procedure or surgery | 2 |
Primary outcome
Primary outcome: comparison of physical functioning score on SF36
Time frame: enrolment, 6 weeks, 3,6 12 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DR. David Sanders, M.D., FRCSC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non operative treatment and operative treatment of ankle fractures in people with Ankle Injuries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: comparison of physical functioning score on SF36 (time frame: enrolment, 6 weeks, 3,6 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.