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Trial Title:
US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma
NCT ID:
NCT05685160
Condition:
Intermetatarsal Bursitis
Morton Neuroma
Intermetatarsal Neuroma
Conditions: Official terms:
Neuroma
Bursitis
Morton Neuroma
Conditions: Keywords:
Forefoot pain
Metatarsalgia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a diagnostic study with a patient and a control group.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRI with contrast
Description:
MRI of the forefoot with contrast (Gadovist)
Arm group label:
Control group
Arm group label:
Patient group
Intervention type:
Diagnostic Test
Intervention name:
Ultrasound
Description:
Ultrasound imaging of the forefoot
Arm group label:
Control group
Arm group label:
Patient group
Summary:
The aim of this study is to investigate the incidence of intermetatarsal bursitis and
Morton's neuroma in patients with metatarsalgia (i.e. pain in the forefoot) and control
subjects by diagnostic imaging with ultrasound and MRI.
Detailed description:
In a group of patients with intermetatarsal pain found by an orthopedic surgeon, the
investigators want to assess the incidences of intermetatarsal bursitis and Morton's
neuroma, using diagnostic imaging; ultrasound and MRI.
The hypothesis is, that intermetatarsal bursitis is an overlooked diagnosis in patients
with metatarsalgia. As a result of sparse literature and lack of knowledge about this
condition with symptoms mimicking Morton's neuroma, a part of patients diagnosed with
Morton's neuroma, suffers from intermetatarsal bursitis instead.
Additionally, the investigators want to evaluate the clinical sign opening toes.
Based on clinical photos of the feet, the investigators want to document the presence of
opening toes and investigate if there is a correlation with either intermetatarsal
bursitis and/or Morton's neuroma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age > 18 years
- Pain in an intermetatarsal space (patient group)
Exclusion Criteria:
- Age <18 years
- Open wounds or ongoing infection in the forefoot at the time of examination
- Persons with contraindications to participate in MRI scan
- Persons with a history of significant trauma in the forefoot, e.g. any fracture or
previous surgeries in the forefoot
- Persons who have previously received treatment for Morton's neuroma in the same
foot, e.g. injection (within 6 months) or operation (anytime)
- Persons with severely impaired renal function (GFR <30 ml/min)
- Persons with a systemic inflammatory condition like rheumatoid arthritis, due to
clinically silent intermetatarsal bursitis in this group (control group)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Radiology
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Sif B Larsen, MD
Phone:
+45 21457551
Email:
binderlarsen@gmail.com
Start date:
June 14, 2021
Completion date:
March 2024
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
The Danish Rheumatism Association
Agency class:
Other
Collaborator:
Agency:
Hvidovre University Hospital
Agency class:
Other
Collaborator:
Agency:
Bispebjerg Hospital
Agency class:
Other
Collaborator:
Agency:
Gentofte Hospital
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05685160
