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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT/CT | Diagnostic Test | SPECT/CT of the foot and ankle | ||
| MRI | Diagnostic Test | MRI of the foot and ankle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur van Hasselt, MD | Contact | 0031646345384 | a.vanHasselt@mzh.nl | |
| Astrid de Vries, dr | Contact | A.deVries3@mzh.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tom van Raaij, MD/PhD | Martini Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martini Hospital | Recruiting | Groningen | 9728 NT | Netherlands |
Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |