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Enrolling By InvitationNCT07028944

Analysis of Medial Clear Space Widening in Weber B Ankle Fractures

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

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers

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 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: 1. manual external rotation stress; 2. gravity assisted stress; 3. 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

Interventions

TypeNameDescription
OTHERGravity assisted stressPatients have a post 7-10 day ankle fracture x-ray taken under gravity assisted stress
OTHERManual external rotation stressPatients have a post 7-10 day ankle fracture x-ray taken under manual external rotation stress
OTHERWeight-bearing stressPatients have a post 7-10 day ankle fracture x-ray taken under manual weigh-bearing stress

Timeline

Start date
2023-05-25
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2025-06-19
Last updated
2025-06-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07028944. Inclusion in this directory is not an endorsement.