Detecting and Assessing Leg and Foot Stress Fractures Using Photon Counting CT (FootPCCT)

March 27, 2024 updated by: Balgrist University Hospital

Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography

Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone strength and chronic stress applied to the bone. The vast majority of these fractures occur in the lower extremity. Early-stage diagnosis is crucial to optimize patient care. Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected. MRI has a high sensitivity, but its availability is limited, and its respective examination time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity stress fractures as a dose-saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stress fracture is caused by the mismatch between bone strength and chronical stress applied to the bone, which is insufficient to cause an acute fracture, but a stress fracture does not heal itself. One can subclassify it into fatigue fracture (overuse of a healthy bone) and insufficiency fracture (normal use of a weakened bone). Fatigue fractures usually happen in healthy athletes or military recruits, whereas insufficiency fracture appear in patients with underlying metabolic or nutritional disorder (e.g. osteoporosis). On radiographs and Computed Tomography (CT), stress fractures are defined as round or linear intracortical lucency or an intertrabecular sclerotic line, which rarely intersects the cortex. Radiograph is a cost-effective and highly available modality in detecting fractures, showing however a moderate sensitivity in detecting stress fractures: 15-35% on the initial and 30-70% on the follow-up imaging. CT, another modality highly available in most hospital settings, shows a similar moderate sensitivity of 32-38% with however a corresponding high specificity of 88-98% on initial imaging. Similar specificity values can be observed for magnetic resonance imaging (MRI) and nuclear scintigraphy. Although their availability is limited and their respective examination time is prolonged, they outperform the x-ray based technologies in term of sensitivity (68-98% MRI and 50-97% nuclear scintigraphy, respectively).

The introduction of dual-energy technology advanced CT from a pure anatomical evaluation tool to a combined anatomical and functional modality. Every material has a specific absorption number, which can be assessed by applying two different energies (high and low x-ray tube voltages). This method of multispectral imaging has been established and clinically implemented in detecting gout and characterizing renal stones. Further studies have shown that DECT can depict bone marrow edema, a marker of early stress fracture and a common finding in MRI. However, this has yet not been implemented in clinical practice.

The photon-counting-computed-tomography (PCCT) has been introduced recently, enabling an energy dependent separation of photons over the whole x-ray energy spectrum. This results in reduced background noise, improved image resolution and multispectral imaging without the necessity of an additional acquisition at a different energy level. An initial study has shown already shown the superiority of PCCT by better detecting and characterizing small renal stones, when compared to conventional dual-energy computed tomography (DECT).

In this project the investigators aim to include clinically referred patients with suspected stress fracture of the lower extremity who will have an MRI to confirm the diagnosis of a suspected stress fracture. The subjects will be scanned on the new PCCT system with dose saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable). The investigators will not inject iodine contrast media and they will expect a median dose of 2-4 mSv (millisieverts). Since this will not exceed the threshold of 5 mSv, this project will be classified as category A.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8008
        • Recruiting
        • Balgrist University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In cooperation with the Foot Clinic at the Balgrist University Hospital Zurich, potential study candidates with suspected stress fracture who will undergo an MRI to confirm the diagnosis are prospectively screened and proposed to join the study.

Description

Inclusion Criteria:

  • ≥ 16 years of age. Minor study subjects can have an additional signature by the parent or legal guardian
  • Clinically suspected stress or insufficiency fracture of the lower extremity
  • Written consent of study participation
  • Patients who will have an MRI to confirm the diagnosis of a suspected stress fracture

Exclusion Criteria:

  • < 16 years of age
  • Pregnancy
  • Metal implants
  • Postoperative situation
  • Infection or tumorous disease affecting the lower extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of a fracture
Time Frame: Day 1, 4weeks follow up assessment
Presence/absence of a fracture
Day 1, 4weeks follow up assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of bone edema
Time Frame: Day 1, 4weeks follow up assessment
Presence/absence of bone edema
Day 1, 4weeks follow up assessment
Presence of soft tissue edema
Time Frame: Day1, 4weeks follow up assessment
Presence/absence of soft tissue edema
Day1, 4weeks follow up assessment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain localization
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain localization will be done through a clear statement of anatomical location
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain character
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain will be characterized using the following terms: sharp, dull, aching, burning, radiating, numbing, and pulsating.
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain intensity
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain intensity will be described using the Number Rating Scale (NRS): a score of 0 corresponds to the absence of pain, while a score of 10 indicates the most intense pain ever experienced.
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain duration
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain duration is described in days (d).
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Karlsson Scoring Scale: Patient reported outcome regarding the stress fracture
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
The Karlsson scoring scale is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The scoring system comprises a total of 90 points, where 0 points represent the most severe condition and 90 points indicate an absence of any issues.
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Foot Function Index: Patient reported outcome regarding the stress fracture
Time Frame: Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
The Foot Function Index is utilized to evaluate and quantify both the functional status and the extent to which the stress fracture affects an individual's quality of life. The minimum score is 0% (no pain or difficulty), and maximum score is 100%
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Principal Investigator: Stephan Wirth, PD Dr.med., Balgrist University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W1024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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