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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment
Ankle Fracture - Lateral Malleolus Procedure: Surgery Procedure: Conservative treatment

Detailed 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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control group
age and sex matched healthy control persons
Surgery
patients with ankle fracture treated surgically
Procedure: Surgery
Surgical fracture fixation

Conservative treatment
patients with ankle fracture treated conservatively
Procedure: Conservative treatment
immobilisation with plaster cast




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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 [ 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
20 patients with Weber B1 treated surgically; 20 patients with Weber B1 treated conservatively; 20 age and sex matched healthy control persons
Criteria

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

Information from the National Library of Medicine

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


Locations
Switzerland
University Hospital Basel
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Annegret Mündermann, PhD University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03539029     History of Changes
Other Study ID Numbers: 2018-00513
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries