Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis (WEBER)
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|ClinicalTrials.gov Identifier: NCT03539029|
Recruitment Status : Enrolling by invitation
First Posted : May 28, 2018
Last Update Posted : June 8, 2018
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.
|Condition or disease||Intervention/treatment|
|Ankle Fracture - Lateral Malleolus||Procedure: Surgery Procedure: Conservative treatment|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||April 30, 2020|
age and sex matched healthy control persons
patients with ankle fracture treated surgically
Surgical fracture fixation
patients with ankle fracture treated conservatively
Procedure: Conservative treatment
immobilisation with plaster cast
- 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
- single leg balance [ Time Frame: Baseline ]length of center of pressure during 30sec single leg stance measured in mm
- ankle power [ Time Frame: Baseline ]dynamic ankle power during walking measured in Nm/s
- Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion [ Time Frame: Baseline ]Max moment assessed using a Biodex measured as Nm
- Lower leg muscle activation [ Time Frame: Baseline ]Max electromyographic signal intensity measured in mV
- clinical outcome [ Time Frame: Baseline ]assessed using the Foot and Ankle Outcome score (100 - no problems, 0 - extreme problems)
- 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)
- pain [ Time Frame: Baseline ]assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539029
|University Hospital Basel|
|Basel, Basel Stadt, Switzerland, 4031|
|Principal Investigator:||Annegret Mündermann, PhD||University Hospital, Basel, Switzerland|