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

M

Martini Hospital Groningen

Status

Enrolling

Conditions

Osteoarthritis
Osteoarthritis Ankle

Treatments

Diagnostic Test: SPECT/CT
Diagnostic Test: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT05912153
ProSPECT study

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Arthur van Hasselt, MD; Astrid de Vries, dr

Data sourced from clinicaltrials.gov

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