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
NCT number | NCT04441983 |
Other study ID # | R449 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | October 31, 2025 |
- 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.).
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Balgrist University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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