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Clinical Trials in Denmark / NCT05685160
Enrolling by invitation Not applicable

US and MRI of the Forefoot: Intermetatarsal Bursitis or Morton's Neuroma

NCT05685160 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2021-06-14
Last updated
2024-11-15

Condition(s) studied

Intermetatarsal BursitisMorton NeuromaIntermetatarsal Neuroma

Investigational drug(s) / intervention(s)

MRI with contrastUltrasound

MRI with contrast: MRI of the forefoot with contrast (Gadovist)

Ultrasound: Ultrasound imaging of the forefoot

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Incidence of intermetatarsal bursitis on MRI — 8 weeks
    High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
  • Incidence of intermetatarsal bursitis on US — 8 weeks
    Hypoechoic mass between metatarsal heads closest to dorsal surface of foot. Compressible. Activity on power/color doppler.
  • Incidence of Morton's neuroma on MRI — 8 weeks
    Low to Intermediate signal in T1 and T2. Contrast enhancement of the nodular focus.
  • Incidence of Morton's neuroma on US — 8 weeks
    Hypoechoic mass between metatarsal heads closest to plantar surface of foot. Non-compressible. The interdigital nerve can be seen entering the mass. Close relation to the interdigital artery.
  • Incidence of other pathology on MRI — 8 weeks
    Other pathology than intermetatarsal bursitis or Morton's neuroma.
  • Incidence of other pathology on US — 8 weeks
    Other pathology than intermetatarsal bursitis or Morton's neuroma.
  • Incidence of normal findings on MRI — 8 weeks
    When no findings is observed.
  • Incidence of normal findings on US — 8 weeks
    When no findings is observed.

Trial sites (1)

FacilityCityRegionStatus
Department of Radiology Copenhagen Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685160 on ClinicalTrials.gov ↗ ← All trials in Denmark