Plantar Plate TearNCT04441983
Foot/Extremities at 7T MRI
An observational study of Plantar Plate Tear, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
To evaluate standard clinical sequences for 7 Tesla MRI of the foot and extremities to improve detailed depiction of the complex anatomy of this region. To evaluate various pathologies of the foot and extremities (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Plate Tear
- What is being tested?
- 7 Tesla MRI of the foot
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jun 2021to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have undergone a forefoot MRI for clinical indications (or previous study) will be enrolled
Who may be able to join
- 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.
Who cannot join
- previous foot/ extremities surgery with metal in vivo
- pregnancy or breast feeding
- any MRI contra-indications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Christoph Germann, MD, +41443863322, christoph.germann@balgrist.ch
About this study
Official title: 7 TESLA MRI EVALUATION OF THE FOOT AND EXTREMITIES
- To evaluate standard clinical sequences for 7 Tesla MRI of the foot and extremities to improve detailed depiction of the complex anatomy of this region.
- To evaluate various pathologies of the foot and extremities (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).
- Conditions
- Plantar Plate Tear
- Being tested
- 7 Tesla MRI of the foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 Tesla MRI of the footDiagnostic test
7 Tesla MRI
| Study group | Role | What they receive |
|---|---|---|
| 7T MRI of the foot | Not described Receives: Diagnostic Test: 7 Tesla MRI of the foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start25 Jun 2021
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Plate TearStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto Sutter, MD, Study director, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441983
- Sponsor's protocol ID
- R449
- Status last verified
- Oct 2025
- First submitted
- 19 Jun 2020
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7 TESLA MRI EVALUATION OF THE FOOT AND EXTREMITIES
- ClinicalTrials.gov ID
- NCT04441983
- Acronym / sponsor ID
- R449
- Conditions
- Plantar Plate Tear
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2020 (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.
- To evaluate standard clinical sequences for 7 Tesla MRI of the foot and extremities to improve detailed depiction of the complex anatomy of this region.
- To evaluate various pathologies of the foot and extremities (plantar plate tears, Morton neuroma, tendon tears, ligament tears etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7T MRI of the foot | – | Diagnostic Test: 7 Tesla MRI of the foot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a forefoot MRI for clinical indications (or previous study) will be enrolled
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- previous foot/ extremities surgery with metal in vivo
- pregnancy or breast feeding
- any MRI contra-indications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 Tesla MRI of the foot7 Tesla MRI | Diagnostic test | 7T MRI of the foot |
Primary outcome
sensitivity / specificity
Time frame: 2 years
The sensitivity/specificity for detection of various pathologies in the foot/ankle, for exampleMorton neuroma, plantar plate tears and tendon injuries at 7T MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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.
Reto Sutter, MD study director
Balgrist University Hospital
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 Plantar Plate Tear, run by Balgrist University Hospital at 1 site in Switzerland.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christoph Germann, MD (+41443863322, christoph.germann@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity / specificity (time frame: 2 years). 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 16 Jul 2026.