NCT05876897

Brief Summary

The primary purpose of this study is to determine whether or not there is a correlation between MRI and ultrasound for the diagnosis of lower limb stress injuries. Patients that are seen at the University of Iowa Sports Medicine Center with a suspected diagnosis of a lower limb stress injury will be recruited. These patients will undergo a diagnostic ultrasound of the affected region prior to undergoing an MRI of that region. Then, the ultrasound findings will be compared to the MRI findings to determine if a correlation exists.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

3.2 years

First QC Date

May 14, 2023

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • US correlation to MRI

    1 year

Study Arms (1)

Diagnostic Ultrasound

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

25 patients ages 18-50 with a suspected diagnosis of a lower limb stress injury (specifically of the tibia or metatarsal) will be recruited. Patients will excluded if they have a prior history of stress fracture or fracture in the affected limb at the region on concern.

You may qualify if:

  • Age 18-50
  • MRI confirmed tibial or metatarsal stress injury

You may not qualify if:

  • Prior history of stress fracture or fracture in the affected limb at the region of concern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Sports Medicine

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

May 14, 2023

First Posted

May 26, 2023

Study Start

February 3, 2021

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations