CClinicalTrials.gg
RecruitingNCT05912153Updated Feb 27, 2026

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

An observational study in Osteoarthritis Ankle and Osteoarthritis, sponsored by Martini Hospital Groningen. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Martini Hospital Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
132
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis Ankle
  • Osteoarthritis

Browse trials for

Keywords

  • SPECT/CT
  • MRI
  • osteoarthritis
  • Foot and/or Ankle
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible patients subjects will be all patients referred to the Martini Hospital Groningen with suspected OA of the foot and ankle meeting our inclusion criteria. In total 369 patients will be included. A sample of two months showed that 68 new eligible patients were presented at the outpatient clinic with a prevelence of OA in 85%. We assume that at least 50% of the eligible patients are willing to participate in this study, so it is expected that within 24-30 months all patients can be recruited.

Inclusion criteria

  • Suspected symptomatic ankle, hind- or midfoot OA
  • Informed consent
  • Age ≥ 18 years
  • Average NRS ≥4 over the past week.

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
132 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Diagnostic testSPECT/CT

    SPECT/CT of the foot and ankle

  • Diagnostic testMRI

    MRI of the foot and ankle

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Martini Hospital
    Groningen, 9728 NT, Netherlands
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — Only deidentified data will be available upon reasonable written request in conjunction with appropriate data use agreement.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05912153
Lead sponsor
Martini Hospital Groningen
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jul 4, 2023
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Feb 27, 2026

Study contacts

Arthur van Hasselt, MD
Contact
a.vanHasselt@mzh.nl
0031646345384
Astrid de Vries, dr
Contact
A.deVries3@mzh.nl
Tom van Raaij, MD/PhD
principal investigator · Martini Ziekenhuis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion