Analysis of Medial Clear Space Widening in Weber B Ankle Fractures

NCT07028944 | Active Not Recruiting

• 1 other identifier: 162103
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Day 1 Clinic Visit

Study Arms (3)

Gravity assisted stress

Radiograph of ankle fracture under gravity assisted stress (7-10 days post-fracture, one-time clinic visit x-ray).

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, ).

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).

Other: Weight-bearing stress

Interventions

Gravity assisted stress OTHER

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

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

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

Weight-bearing stress

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• Lucas Marchand, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 19, 2025
• Study Start: May 25, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)