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Recruiting NCT05912153

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

Observational Osteoarthritis Ankle Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPECT/CT, MRI.
Who it may be relevant to
Registry conditions: Osteoarthritis Ankle, Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test SPECT/CT
    SPECT/CT of the foot and ankle
  • Diagnostic test MRI
    MRI of the foot and ankle

Primary outcome measures

  • Diagnostic accuracy of SPECT/CT and MRI [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Martini Hospital — Groningen

Identifiers

NCT: NCT05912153 · ProSPECT study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗