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NCT Number: NCT07028944

Analysis of Medial Clear Space Widening in Weber B Ankle Fractures

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

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

Inclusion criteria

  • Patients with a Weber B ankle fracture who are skeletally mature (no open physes) and older than 18 years of age.

Exclusion criteria

  • 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

Treatment and study plan

Gravity assisted stress

Other

Patients have a post 7-10 day ankle fracture x-ray taken under gravity assisted stress

Manual external rotation stress

Other

Patients have a post 7-10 day ankle fracture x-ray taken under manual external rotation stress

Weight-bearing stress

Other

Patients have a post 7-10 day ankle fracture x-ray taken under manual weigh-bearing stress

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Prospective Analysis of Medial Clear Space Widening in Weber B Ankle Fractures: A Comparison of Three Methods

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 19, 2025
Registry last updated
Apr 23, 2026

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.