SPECT-CT vs MRI for the Diagnosis of Osteoarthritis in the Foot and Ankle

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMartini Hospital Groningen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Suspected symptomatic ankle, hind- or midfoot OA

Informed consent

Age ≥ 18 years

Average NRS ≥4 over the past week.

Disqualifiers

Contraindication for surgery

Contraindication for SPECT-CT or MRI

Contraindication for intra-articular injections

Isolated forefoot pathology

Trial population

Eligible patients subjects will be all patients referred to the Martini Hospital Groningen with suspected OA of the foot and ankle meeting our inclusion criteria. In total 369 patients will be included. A sample of two months showed that 68 new eligible patients were presented at the outpatient clinic with a prevelence of OA in 85%. We assume that at least 50% of the eligible patients are willing to participate in this study, so it is expected that within 24-30 months all patients can be recruited.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SPECT/CT

    Diagnostic test

    SPECT/CT of the foot and ankle

  • MRI

    Diagnostic test

    MRI of the foot and ankle

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of SPECT/CT and MRI

Primary objective is to determine overall diagnostic performance (in terms of sensitivity + specificity, positive and negative predictive values, positive and negative likelihood ratios, and diagnostic odds ratio) of SPECT-CT and MRI for diagnosing symptomatic OA in the ankle, hind- and midfoot.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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