Weber B Ankle FracturesNCT07028944
Analysis of Medial Clear Space Widening in Weber B Ankle Fractures
An observational study of Weber B Ankle Fractures, run by University of Utah at 1 site in United States.
Trial summary
The investigators purpose of this study is to obtain all three standard of care stress views of the ankle (gravity stress, manual stress, weightbearing stress) to compare the amount of tibiotalar joint instability predicted by each to determine if there are significant differences measured by the differing stress… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Weber B Ankle Fractures
- What is being tested?
- Gravity assisted stress, Manual external rotation stress and Weight-bearing stress
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2023to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients older than 18 years of age with a Weber B ankle fracture who are skeletally mature (no open physes).
Who may be able to join
- Patients with a Weber B ankle fracture who are skeletally mature (no open physes) and older than 18 years of age.
Who cannot join
- Medial and/or posterior Malleolar fracture
- Any other lower extremity trauma that limits weight bearing
- Concomitant arthridities/rheumatologic disease (patients with osteoarthritis may be included)
- Prior fracture
- Prior surgery of foot, talus or ankle
- Open fracture
- Initial NWB xrays with a medial clear space (MCS) > 7 mm or medial clear space> superior clear space (SCS) by 2mm, signifying an unstable fracture prior to stress
- Protected populations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Prospective Analysis of Medial Clear Space Widening in Weber B Ankle Fractures: A Comparison of Three Methods
The investigators purpose of this study is to obtain all three standard of care stress views of the ankle (gravity stress, manual stress, weightbearing stress) to compare the amount of tibiotalar joint instability predicted by each to determine if there are significant differences measured by the differing stress techniques.
Read the detailed description
Rotational ankle injuries are a commonly encountered injury. Classification of these injuries is most commonly by the Danis-Weber (or Weber) classification and the Lauge-Hansen classification.
Within this classification system exists the isolated Weber B or Lauge-Hansen Supination External Rotation 2/4 (SER 2/4) injury which radiographically involves an isolated spiral fracture of the lateral malleolus at the level of the tibiofibular syndesmosis.
The difference between SER2 (isolated) Weber B injuries and SER4 injuries is disruption of the medial ankle mortise structures, either the medial malleolus (4a) or deltoid ligaments (4b) which then can permit increased talar subluxation with potential to result in tibitotalar joint incongruity.
Standard practice is to proceed with operative fixation of rotationally unstable Weber B or SER4b injuries.
To determine the competence of medial ligamentous structures in isolated fractures of the fibula at the level of the syndesmosis when there is minimal widening of the mortise on non weight bearing films there are three plain x-ray views currently widely used and considered standard of care:
- manual external rotation stress;
- gravity assisted stress;
- and weight-bearing stress radiographs.
Increased widening on one of these views is used to decide whether to treat the fracture with or without surgery.
Globally there is wide variability as to which stress-view radiograph or combination of these are used. To our knowledge, no study to date has compared all three stress-view radiographs concurrently to determine if the three different methods predict equal amounts of tibiotalar joint instability.
The need to understand how these three views compare is crucial, as tibiotalar instability is primary indication for surgical stabilization.
The null hypothesis therefore is the investigators will find no difference in the tibiotalar joint instability between the three stress views.
- Conditions
- Weber B Ankle Fractures
- Being tested
- Gravity assisted stress, Manual external rotation stress, Weight-bearing stress
- Keywords
- Weber B ankle fractures, Medial Clear Space (MCS) Widening, gravity assisted stress (GAS), manual external rotation stress (MERS), weight-bearing stress (WBS), radiographs, X-rays
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gravity assisted stressOther
Patients have a post 7-10 day ankle fracture x-ray taken under gravity assisted stress
Manual external rotation stressOther
Patients have a post 7-10 day ankle fracture x-ray taken under manual external rotation stress
Weight-bearing stressOther
Patients have a post 7-10 day ankle fracture x-ray taken under manual weigh-bearing stress
| Study group | Role | What they receive |
|---|---|---|
| Gravity assisted stress | Radiograph of ankle fracture under gravity assisted stress (7-10 days post-fracture, one-time clinic visit x-ray). Receives: Other: Gravity assisted stress | |
| Manual external rotation stress | Radiograph of ankle fracture under manual external rotation stress (7-10 days post-fracture, one-time clinic visit x-ray, ). Receives: Other: Manual external rotation stress | |
| Weight-bearing stress | Radiograph of ankle fracture under weight-bearing stress (7-10 days post-fracture, one-time clinic visit x-ray). Receives: Other: Weight-bearing stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial Clear Space (MCS) Widening Under Gravity Assisted Stress
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing gravity assisted stress
Measured: Day 1 Clinic Visit
Medial Clear Space (MCS) Widening Under Manual External Rotation Stress
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing manual external rotation stress
Measured: Day 1 Clinic Visit
Medial Clear Space (MCS) Widening Under Weight-bearing Stress
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing weight-bearing stress
Measured: Day 1 Clinic Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start25 May 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weber B Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Marchand, University of Utah
- Investigators
- Lucas Marchand, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028944
- Sponsor's protocol ID
- 162103
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Medial Clear Space Widening in Weber B Ankle Fractures: A Comparison of Three Methods
- ClinicalTrials.gov ID
- NCT07028944
- Acronym / sponsor ID
- 162103
- Conditions
- Weber B Ankle Fractures
- Keywords
- Weber B ankle fractures, Medial Clear Space (MCS) Widening, gravity assisted stress (GAS), manual external rotation stress (MERS), weight-bearing stress (WBS), radiographs, X-rays
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Jun 2025 (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 investigators purpose of this study is to obtain all three standard of care stress views of the ankle (gravity stress, manual stress, weightbearing stress) to compare the amount of tibiotalar joint instability predicted by each to determine if there are significant differences measured by the differing stress techniques.
Detailed description
Rotational ankle injuries are a commonly encountered injury. Classification of these injuries is most commonly by the Danis-Weber (or Weber) classification and the Lauge-Hansen classification.
Within this classification system exists the isolated Weber B or Lauge-Hansen Supination External Rotation 2/4 (SER 2/4) injury which radiographically involves an isolated spiral fracture of the lateral malleolus at the level of the tibiofibular syndesmosis.
The difference between SER2 (isolated) Weber B injuries and SER4 injuries is disruption of the medial ankle mortise structures, either the medial malleolus (4a) or deltoid ligaments (4b) which then can permit increased talar subluxation with potential to result in tibitotalar joint incongruity.
Standard practice is to proceed with operative fixation of rotationally unstable Weber B or SER4b injuries.
To determine the competence of medial ligamentous structures in isolated fractures of the fibula at the level of the syndesmosis when there is minimal widening of the mortise on non weight bearing films there are three plain x-ray views currently widely used and considered standard of care:
- manual external rotation stress;
- gravity assisted stress;
- and weight-bearing stress radiographs.
Increased widening on one of these views is used to decide whether to treat the fracture with or without surgery.
Globally there is wide variability as to which stress-view radiograph or combination of these are used. To our knowledge, no study to date has compared all three stress-view radiographs concurrently to determine if the three different methods predict equal amounts of tibiotalar joint instability.
The need to understand how these three views compare is crucial, as tibiotalar instability is primary indication for surgical stabilization.
The null hypothesis therefore is the investigators will find no difference in the tibiotalar joint instability between the three stress views.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gravity assisted stress | – | Other: Gravity assisted stressRadiograph of ankle fracture under gravity assisted stress (7-10 days post-fracture, one-time clinic visit x-ray). |
| Manual external rotation stress | – | Other: Manual external rotation stressRadiograph of ankle fracture under manual external rotation stress (7-10 days post-fracture, one-time clinic visit x-ray, ). |
| Weight-bearing stress | – | Other: Weight-bearing stressRadiograph of ankle fracture under weight-bearing stress (7-10 days post-fracture, one-time clinic visit x-ray). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years of age with a Weber B ankle fracture who are skeletally mature (no open physes).
Key inclusion criteria (1 listed)
- Patients with a Weber B ankle fracture who are skeletally mature (no open physes) and older than 18 years of age.
Key exclusion criteria (8 listed)
- Medial and/or posterior Malleolar fracture
- Any other lower extremity trauma that limits weight bearing
- Concomitant arthridities/rheumatologic disease (patients with osteoarthritis may be included)
- Prior fracture
- Prior surgery of foot, talus or ankle
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 |
|---|---|---|
| Gravity assisted stressPatients have a post 7-10 day ankle fracture x-ray taken under gravity assisted stress | Other | Gravity assisted stress |
| Manual external rotation stressPatients have a post 7-10 day ankle fracture x-ray taken under manual external rotation stress | Other | Manual external rotation stress |
| Weight-bearing stressPatients have a post 7-10 day ankle fracture x-ray taken under manual weigh-bearing stress | Other | Weight-bearing stress |
Primary outcome
Medial Clear Space (MCS) Widening Under Gravity Assisted Stress
Time frame: Day 1 Clinic Visit
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing gravity assisted stress
Medial Clear Space (MCS) Widening Under Manual External Rotation Stress
Time frame: Day 1 Clinic Visit
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing manual external rotation stress
Medial Clear Space (MCS) Widening Under Weight-bearing Stress
Time frame: Day 1 Clinic Visit
Measured distance, millimeters(mm) of the fractured fibula at the level of the syndesmosis joint in patients undergoing weight-bearing stress
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
Lucas Marchand, M.D. principal investigator
University of Utah Orthopaedics
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 Weber B Ankle Fractures, run by University of Utah at 1 site in United States.
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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Medial Clear Space (MCS) Widening Under Gravity Assisted Stress (time frame: Day 1 Clinic Visit). The study lists 3 primary outcomes in all. 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 23 Apr 2026.