Detecting and Assessing Leg and Foot Stress Fractures Using Photon Counting CT

NCT06024798 | Recruiting

• 1 other identifier: W1024
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stress Fracture Foot; Stress Fracture Ankle; Stress Fracture of Tibia; Stress Fracture Metatarsal; Lower Limb Fracture

Outcome Measures

Primary Outcomes (1)

• Presence of a fracture

  Presence/absence of a fracture

  Day 1, 4weeks follow up assessment

Secondary Outcomes (2)

• Presence of bone edema

  Day 1, 4weeks follow up assessment

• Presence of soft tissue edema

  Day1, 4weeks follow up assessment

Other Outcomes (6)

• Pain localization

  Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment

• Pain character

  Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment

• Pain intensity

  Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment

Interventions

Photon-Counting-Computed-Tomography DIAGNOSTIC_TEST

Initial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (15)

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• Grunz JP, Heidenreich JF, Lennartz S, Weighardt JP, Bley TA, Ergun S, Petritsch B, Huflage H. Spectral Shaping Via Tin Prefiltration in Ultra-High-Resolution Photon-Counting and Energy-Integrating Detector CT of the Temporal Bone. Invest Radiol. 2022 Dec 1;57(12):819-825. doi: 10.1097/RLI.0000000000000901. Epub 2022 Jun 24.

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• Grunz JP, Petritsch B, Luetkens KS, Kunz AS, Lennartz S, Ergun S, Bley TA, Huflage H. Ultra-Low-Dose Photon-Counting CT Imaging of the Paranasal Sinus With Tin Prefiltration: How Low Can We Go? Invest Radiol. 2022 Nov 1;57(11):728-733. doi: 10.1097/RLI.0000000000000887. Epub 2022 May 6.

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Related Links

• Report on the use of patient shielding in radiological procedures Swiss Society of Radiobiology and Medical Physics.

Study Officials

• Stephan Wirth, PD Dr.med.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viehöfer Arnd, PD Dr.med.

CONTACT

+41 44 386 57 55; Arnd.Viehöfer@balgrist.ch

Zendeli Flamur

CONTACT

+41 44 386 56 72; Flamur.Zendeli@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2025
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)