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NCT Number: NCT05912153

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

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.

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Key information

Conditions

Osteoarthritis Ankle Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Martini Hospital

Groningen, 9728 NT, Netherlands

Location status: Recruiting

Location contact

Arthur van Hasselt, MD

CONTACT

[email protected]

0031505245932

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPECT/CT

Diagnostic Test

SPECT/CT of the foot and ankle

MRI

Diagnostic Test

MRI of the foot and ankle

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur van Hasselt, MD

CONTACT

[email protected]

0031646345384

Astrid de Vries, dr

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Martini Hospital Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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