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

NCT05912153 | Recruiting

• 1 other identifier: ProSPECT study
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Ankle; Osteoarthritis

Keywords

SPECT/CT; MRI; osteoarthritis; Foot and/or Ankle

Outcome Measures

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.

  1 year

Interventions

SPECT/CT DIAGNOSTIC_TEST

SPECT/CT of the foot and ankle

MRI DIAGNOSTIC_TEST

MRI of the foot and ankle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Suspected symptomatic ankle, hind- or midfoot OA
• Informed consent
• Age ≥ 18 years
• Average NRS ≥4 over the past week.

You may not qualify if:

• 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

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Hospital

Groningen, 9728 NT, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-Photon; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Tom van Raaij, MD/PhD

  Martini Ziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur van Hasselt, MD

CONTACT

0031646345384; a.vanHasselt@mzh.nl

Astrid de Vries, dr

CONTACT

A.deVries3@mzh.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: July 4, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)