Ankle Fracture - Lateral MalleolusWEBERNCT03539029
Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis
An observational study of Ankle Fracture - Lateral Malleolus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture - Lateral Malleolus
- What is being tested?
- Surgery and Conservative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2018to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 20 patients with Weber B1 treated surgically; 20 patients with Weber B1 treated conservatively; 20 age and sex matched healthy control persons
Who may be able to join
- Age ≥ 18 years
- Surgical or conservative treatment after lateral malleolar fracture
- ≥12 months follow-up
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Ankle Fracture - Lateral Malleolus
- Being tested
- Surgery, Conservative treatment
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical fracture fixation
Conservative treatmentProcedure or surgery
immobilisation with plaster cast
| Study group | Role | What they receive |
|---|---|---|
| Control group | age and sex matched healthy control persons | |
| Surgery | patients with ankle fracture treated surgically Receives: Procedure: Surgery | |
| Conservative treatment | patients with ankle fracture treated conservatively Receives: Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (8)
single leg balance
length of center of pressure during 30sec single leg stance measured in mm
Measured: Baseline
ankle power
dynamic ankle power during walking measured in Nm/s
Measured: Baseline
Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion
Max moment assessed using a Biodex measured as Nm
Measured: Baseline
Lower leg muscle activation
Max electromyographic signal intensity measured in mV
Measured: Baseline
clinical outcome
assessed using the Foot and Ankle Outcome score (100 - no problems, 0 - extreme problems)
Measured: Baseline
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)
Measured: Baseline
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)
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 May 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture - Lateral MalleolusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Mündermann, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539029
- Sponsor's protocol ID
- 2018-00513
- Other IDs
- 2018
- Acronym
- WEBER
- Status last verified
- Mar 2024
- First submitted
- 15 May 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Conservative Treatment of Weber B1 Fracture: Functional Outcome Using Gait Analysis
- ClinicalTrials.gov ID
- NCT03539029
- Acronym / sponsor ID
- WEBER / 2018-00513
- Conditions
- Ankle Fracture - Lateral Malleolus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –age and sex matched healthy control persons |
| Surgery | – | Procedure: Surgerypatients with ankle fracture treated surgically |
| Conservative treatment | – | Procedure: Conservative treatmentpatients with ankle fracture treated conservatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 20 patients with Weber B1 treated surgically; 20 patients with Weber B1 treated conservatively; 20 age and sex matched healthy control persons
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Surgical or conservative treatment after lateral malleolar fracture
- ≥12 months follow-up
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgical fracture fixation | Procedure or surgery | Surgery |
| Conservative treatmentimmobilisation with plaster cast | Procedure or surgery | Conservative treatment |
Primary outcome
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
8 secondary outcomes
single leg balance
Time frame: Baseline
ankle power
Time frame: Baseline
Isokinetic strength in plantarflexion, dorsiflexion, inversion, and eversion
Time frame: Baseline
Lower leg muscle activation
Time frame: Baseline
clinical outcome
Time frame: Baseline
Health related quality of life
Time frame: Baseline
Pain in the ankle joint
Time frame: Baseline
heel rise performance
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Mündermann, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fracture - Lateral Malleolus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D hindfoot and forefoot range of motion during level and uphill walking (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.