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Completed

NCT Number: NCT03539029

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

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.

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Key information

Conditions

Ankle Fracture - Lateral Malleolus Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Surgical fracture fixation

Conservative treatment

Procedure

immobilisation with plaster cast

Primary outcomes

  1. 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

Secondary outcomes

  1. single leg balance

    Time frame: Baseline

    length of center of pressure during 30sec single leg stance measured in mm

  2. ankle power

    Time frame: Baseline

    dynamic ankle power during walking measured in Nm/s

  3. Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion

    Time frame: Baseline

    Max moment assessed using a Biodex measured as Nm

  4. Lower leg muscle activation

    Time frame: Baseline

    Max electromyographic signal intensity measured in mV

  5. clinical outcome

    Time frame: Baseline

    assessed using the Foot and Ankle Outcome score (100 - no problems, 0 - extreme problems)

  6. 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)

  7. 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)

  8. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: WEBER

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 29, 2018
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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