Stress FractureNCT05876897
US vs MRI for Stress Injuries
An observational study of Stress Fracture, run by Ryan Kruse at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Stress Fracture
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
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.
Who may be able to join
- Age 18-50
- MRI confirmed tibial or metatarsal stress injury
Who cannot join
- -Prior history of stress fracture or fracture in the affected limb at the region of concern.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Sports Medicine
Iowa City, Iowa, 52242
About this study
Official title: Correlation Between MRI and Ultrasound for Diagnosis of Lower Limb Bone Stress Injuries
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.
- Conditions
- Stress Fracture
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Ultrasound | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
US correlation to MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start3 Feb 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan Kruse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ryan Kruse, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876897
- Sponsor's protocol ID
- 202010068
- Status last verified
- Jun 2024
- First submitted
- 14 May 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between MRI and Ultrasound for Diagnosis of Lower Limb Bone Stress Injuries
- ClinicalTrials.gov ID
- NCT05876897
- Acronym / sponsor ID
- 202010068
- Conditions
- Stress Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ryan KruseUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Ultrasound | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age 18-50
- MRI confirmed tibial or metatarsal stress injury
Key exclusion criteria (1 listed)
- -Prior history of stress fracture or fracture in the affected limb at the region of concern.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
US correlation to MRI
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
Related trials for Stress Fracture
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
RecruitingObservational study
Bone Stress Injury Recovery and Return to Sport: A Natural History Study
Bone Stress Fracture
RecruitingPhase 2
Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)
Acute Stress Reaction, Acute Stress Disorder
RecruitingPhase 3
Morphine or Ketamine for Analgesia
Abdominal Pain, Isolated Extremity Fracture
Active, not recruiting
The Human Stress Response in a Simulated ED Setting
Stress Physiology, Stress Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Fracture, run by Ryan Kruse at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
US correlation to MRI (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.