Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis

Ankle Fracture - Lateral Malleolus Clinical Trial

— WEBER  

Official title:

Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539029
• Other study ID #: 2018-00513
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

At the initial assessment, written informed consent will be obtained before participants will undergo a clinical exam (inspection and palpation of the foot, measurement of bilateral passive ankle range of motion). All participants will complete the Foot and Ankle Outcome score and the EQ-5D-5L health questionnaire to obtain pain and functional scores. Participants will be able to familiarize with treadmill walking at their preferred walking speed. Surface electrodes will be placed bilaterally over the tibialis anterior, gastrocnemius medialis and lateralis, soleus, and peroneus longus. Isokinetic muscle strength in ankle plantarflexion/ dorsiflexion will be tested using the Biodex system 4 Pro. Reflective surface markers will be placed bilaterally on anatomic landmarks according to the PlugIn Gait model9 and a specific foot model. These markers are seen by 8 Vicon cameras. Data for a standing reference trial will be collected, and participants will be asked to walk back and forth on a flat walkway until three valid left and right steps will be recorded (force plate hit centrally, approximately 10 minutes). Then, they will be asked to balance on one leg for 30 seconds per leg. Participants will be asked to stand on the treadmill (h/p cosmos, Zebris), and they will perform three single-limb heel rises with each leg while kinematic, electromyography (EMG), and pressure data will be measured. Participants will then walk barefoot for 2 minutes at 0% slope while kinematic, EMG, and pressure data will be recorded. Subsequently, the treadmill incline will be increased to 15%, and data for 2 minutes walking at this slope will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fracture - Lateral Malleolus
• Ankle Fractures
• Fractures, Bone

Intervention

Procedure:
• Surgery
Surgical fracture fixation
• Conservative treatment
immobilisation with plaster cast

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D hindfoot and forefoot range of motion during level and uphill walking	assessed in degrees as max plantarflexion to max dorsiflexion of the ankle using marker and camera based motion capture	Baseline
Secondary	single leg balance	length of center of pressure during 30sec single leg stance measured in mm	Baseline
Secondary	ankle power	dynamic ankle power during walking measured in Nm/s	Baseline
Secondary	Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion	Max moment assessed using a Biodex measured as Nm	Baseline
Secondary	Lower leg muscle activation	Max electromyographic signal intensity measured in mV	Baseline
Secondary	clinical outcome	assessed using the Foot and Ankle Outcome score (100 - no problems, 0 - extreme problems)	Baseline
Secondary	Health related quality of life	assessed using the EQ-5D-5L health questionnaire (100 - best healthy you can imagine; 0 - worst health you can imagine)	Baseline
Secondary	Pain in the ankle joint	assessed using a 15 cm visual analogue scale converted to 0 to 100 scale (0 - no pain; 100 - worst pain imaginable)	Baseline
Secondary	heel rise performance	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