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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912153
• Other study ID #: ProSPECT study
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Martini Hospital Groningen
• Contact: Arthur van Hasselt, MD
• Phone: 0031646345384
• Email: a.vanHasselt[@]mzh.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Ankle

Intervention

Diagnostic Test:
• SPECT/CT
SPECT/CT of the foot and ankle
• MRI
MRI of the foot and ankle

Locations

Country	Name	City	State
Netherlands	Martini Hospital	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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