- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05912153
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Arthur van Hasselt, MD
- Phone Number: 0031646345384
- Email: a.vanHasselt@mzh.nl
Study Contact Backup
- Name: Astrid de Vries, dr
- Email: A.deVries3@mzh.nl
Study Locations
-
-
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Groningen, Netherlands, 9728 NT
- Recruiting
- Martini Hospital
-
Contact:
- Arthur van Hasselt, MD
- Phone Number: 0031505245932
- Email: a.vanHasselt@mzh.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of SPECT/CT and MRI
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tom van Raaij, MD/PhD, Martini Ziekenhuis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Radiography
- Image Interpretation, Computer-Assisted
- Radiographic Image Enhancement
- Image Enhancement
- Photography
- Tomography, X-Ray
- Tomography, Emission-Computed
- Radionuclide Imaging
- Diagnostic Techniques, Radioisotope
- Tomography, X-Ray Computed
- Multimodal Imaging
- Tomography, Emission-Computed, Single-Photon
- Single Photon Emission Computed Tomography Computed Tomography
Other Study ID Numbers
- ProSPECT study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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