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RecruitingNCT05912153

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

SPECT-CT Versus MRI for the Diagnosis of Symptomatic Osteoarthritis in the Ankle, Hind- and Midfoot.

Status
Recruiting
Phase
Study type
Observational
Enrollment
132 (estimated)
Sponsor
Martini Hospital Groningen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Objective: The objective is to determine diagnostic performance of SPECT-CT and MRI when used routinely in patients with symptomatic OA of the ankle, hind- and midfoot. Study design: Prospective cohort study. Study population: All patients ≥18years old, referred to the Martini Hospital Groningen department of Orthopedic surgery with suspected symptomatic osteoarthritis of the foot and ankle and rest pain of NRS ≥4. Main study parameters/endpoints: Main parameters will be the diagnostic performance (a.o. sensitivity and specificity, positive and negative predictive value)of SPECT-CT and MRI. The standard work up consist of questionnaires, detailed physical examination, conventional radiographic, MRI, SPECT-CT imaging and ultrasound guided injections. There are no additional risks for participating in this study compared to current standardised hospital workup.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSPECT/CTSPECT/CT of the foot and ankle
DIAGNOSTIC_TESTMRIMRI of the foot and ankle

Timeline

Start date
2023-07-04
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2023-06-22
Last updated
2026-02-27

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05912153. Inclusion in this directory is not an endorsement.