NCT05912153 SPECT-CT vs MRI for the Diagnosis of Osteoarthritis in the Foot and Ankle
| NCT ID | NCT05912153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Martini Hospital Groningen |
| Condition | Osteoarthritis Ankle |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-07-04 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2023-07-04 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The diagnose of symptomatic osteoarthritis in the ankle, mid- and hind foot remains challenging. There is no gold standard for the work-up and various hospitals use different protocols. Current literature shows a promising role for SPECT-CT imaging in ankle, hind- and midfoot OA. In a previous study investigating the role of SPECT-CT in a reproducible group we have observed a change in diagnosis in 53% when SPECT-CT data was added to the data of conventional workup alone. In 26% of patients addition of SPECT-CT data resulted in change of the original treatment plan. To our knowledge no prospective studies are available on this subject for both SPECT-CT and MRI. In our clinic both SPECT-CT and MRI are used in the work-up for patients with ankle, hind- and midfoot pain. Although we experience good result with SPECT-CT, MRI might be able to detect symptomatic OA as well. Moreover MRI provide more information about soft tissue and is less harmful for the patient in comparison to SPECT-CT. The aim of this study is to determine the diagnostic performance of SPECT-CT and MRI when used routinely in patients with symptomatic OA of the ankle, hind- and midfoot.
Eligibility Criteria
Inclusion Criteria: * Suspected symptomatic ankle, hind- or midfoot OA * Informed consent * Age ≥ 18 years * Average NRS ≥4 over the past week. Exclusion Criteria: * Contraindication for surgery * Contraindication for SPECT-CT or MRI * Contraindication for intra-articular injections * Isolated forefoot pathology * Fracture, ligamentous or tendon injury of the ankle, hind- and/or midfoot trauma within one year before presentation * History of neurological disease * History of foot and/or ankle surgery (affected side) * Inability to read and understand the written information
Contact & Investigator
Tom van Raaij, MD/PhD
PRINCIPAL INVESTIGATOR
Martini Ziekenhuis
Frequently Asked Questions
Who can join the NCT05912153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis Ankle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05912153 currently recruiting?
Yes, NCT05912153 is actively recruiting participants. Contact the research team at a.vanHasselt@mzh.nl for enrollment information.
Where is the NCT05912153 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT05912153 clinical trial?
NCT05912153 is sponsored by Martini Hospital Groningen. The principal investigator is Tom van Raaij, MD/PhD at Martini Ziekenhuis. The trial plans to enroll 132 participants.