Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

Supination-external Rotation Ankle Fractures Clinical Trial

Official title:

Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599441
• Other study ID #: 733368-1
• Status: Completed
• Start date: February 2016
• Est. completion date: February 2, 2017

Study information

• Verified date: October 2019
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2, 2017
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• willing & able to provide written informed consent

• at least 18 years-old

• have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray

Exclusion Criteria:

• pregnant (females)

• prisoners

• open fracture

• clinical signs of foot deformity

• previous foot trauma or surgery on the affected foot

• significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot

• unable to stand in the weight bearing position during the CT scan

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Supination-external Rotation Ankle Fractures

Locations

Country	Name	City	State
United States	UBMD Orthopaedics & Sports Medicine	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medial Clear Space Distance in the Ankle Joint	measured on weight bearing CBCT	Baseline- single-day study
Secondary	Medial Clear Space on Gravity Stress Xray		Baseline
Secondary	Medial Clear Space on Standard Xray		Baseline