- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539029
Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis (WEBER)
The decision whether to operate an ankle fracture or not is often highly dependent on the surgeon's individual judgment. There is consensus that non-displaced Weber A-type fractures rarely require operative treatment, and that Weber C-type or grossly displaced fractures are unstable and therefore require surgery. The decision for appropriate treatment is less clear for minimally displaced Weber B-type ankle fractures, and especially Weber B1 fractures are treated either surgically or conservatively at our clinic.
Conservative management of ankle fractures generally comprises immobilisation in a below-knee VacoPed or cast for six weeks to stabilise the fracture and allow osseous and soft tissue healing. Surgical treatment involves the reduction (if displaced) of the fractured fragments and fixation using various devices such as metal plates, screws, or intramedullary rods. While patients show changes in plantar pressure distribution during gait 18 months after surgical treatment of ankle fractures, to date the functional outcome regarding ankle joint mechanics during daily activities are unknown. Understanding gait function is important because compromised function may not only limit a persons daily activities but also may lead to secondary conditions such as osteoarthritis at the ankle or at adjacent joints.
The primary objective is:
• To compare differences in hindfoot and forefoot kinematics between level and uphill treadmill walking in relation to passive range of motion
The secondary objectives are:
- To compare ankle biomechanics during overground walking and level and uphill treadmill walking between patients with Weber B1 fracture treated either surgically or conservatively and healthy control persons.
- To determine the relationship between passive ankle range of motion, lower leg muscle strength and dynamic ankle range of motion.
- To determine the relationship between lower leg muscle strength and balance.
- To determine the relationship between dynamic range of motion and the Foot and Ankle Outcome Score.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Basel Stadt
-
Basel, Basel Stadt, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Surgical or conservative treatment after lateral malleolar fracture
- ≥12 months follow-up
Exclusion Criteria:
- Neuromuscular disorders affecting gait
- Additional pathologies that influence the mobility of the ankle joint
- Bilateral trauma at presentation
- Persistent use of walking aids
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
age and sex matched healthy control persons
|
|
Surgery
patients with ankle fracture treated surgically
|
Surgical fracture fixation
|
Conservative treatment
patients with ankle fracture treated conservatively
|
immobilisation with plaster cast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3D hindfoot and forefoot range of motion during level and uphill walking
Time Frame: Baseline
|
assessed in degrees as max plantarflexion to max dorsiflexion of the ankle using marker and camera based motion capture
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
single leg balance
Time Frame: Baseline
|
length of center of pressure during 30sec single leg stance measured in mm
|
Baseline
|
ankle power
Time Frame: Baseline
|
dynamic ankle power during walking measured in Nm/s
|
Baseline
|
Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion
Time Frame: Baseline
|
Max moment assessed using a Biodex measured as Nm
|
Baseline
|
Lower leg muscle activation
Time Frame: Baseline
|
Max electromyographic signal intensity measured in mV
|
Baseline
|
clinical outcome
Time Frame: Baseline
|
assessed using the Foot and Ankle Outcome score (100 - no problems, 0 - extreme problems)
|
Baseline
|
Health related quality of life
Time Frame: Baseline
|
assessed using the EQ-5D-5L health questionnaire (100 - best healthy you can imagine; 0 - worst health you can imagine)
|
Baseline
|
Pain in the ankle joint
Time Frame: Baseline
|
assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)
|
Baseline
|
heel rise performance
Time Frame: Baseline
|
To assess the single-limb heel rise ability, participants will complete three single-limb heel rise to maximum possible height.
Heel rises will be performed with straight knees
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Annegret Mündermann, PhD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-00513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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