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

NCT ID: NCT05912153

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2026-06-30

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.

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

Osteoarthritis Ankle; Osteoarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SPECT/CT

SPECT/CT of the foot and ankle

Intervention Type: DIAGNOSTIC_TEST

MRI

MRI of the foot and ankle

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martini Hospital Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tom van Raaij, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Martini Ziekenhuis

Locations

Martini Hospital

Groningen, Provincie Groningen, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Arthur van Hasselt, MD

Role: CONTACT

a.vanHasselt@mzh.nl

0031646345384

Astrid de Vries, dr

Role: CONTACT

A.deVries3@mzh.nl

Facility Contacts

Arthur van Hasselt, MD

Role: primary

a.vanHasselt@mzh.nl

0031505245932

Other Identifiers

ProSPECT study

Identifier Type: -

Identifier Source: org_study_id