Foot/Ankle at 7T MRI

Plantar Plate Tear Clinical Trial

Official title:

High-Resolution MRI (7 Tesla) Findings of the Plantar Plate Compared With Current Clinical Standard Sequences (1.5 or 3 Tesla) and Surgical Reference Standard

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441983
• Other study ID #: R449
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2023
• Source: Balgrist University Hospital
• Contact: Christoph Germann, MD
• Phone: +41443863322
• Email: christoph.germann[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To evaluate standard clinical sequences for 7 Tesla MRI of the foot and/or ankle to improve detailed depiction of the complex anatomy of this region.

• To evaluate various pathologies of the foot and/or ankle (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent as documented by signature (Appendix Informed Consent Form)

• at least 18 years old

• Study group: Patients with specific pathologies (i.e. Morton neuroma, tendon tears, plantar plate tears) as proven by 1,5 or 3T MRI or asymptomatic subjects (to look at the normal microanatomy of different structures, mainly the plantar plate)

• Control group: No evidence of the respective pathology.

Exclusion Criteria:

• previous foot surgery with metal in vivo

• pregnancy or breast feeding

• any MRI contra-indications

Related Conditions & MeSH terms

• Plantar Plate Tear

Intervention

Diagnostic Test:
• 7 Tesla MRI of the foot
7 Tesla MRI

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity / specificity	The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI	2 years