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

Sponsor
Martini Hospital Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05912153
Collaborator
(none)
132
1
23.4
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: SPECT/CT
  • Diagnostic Test: MRI

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
132 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SPECT-CT Versus MRI for the Diagnosis of Symptomatic Osteoarthritis in the Ankle, Hind- and Midfoot.
Anticipated Study Start Date :
Jun 19, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Diagnostic accuracy of SPECT/CT and MRI [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Suspected symptomatic ankle, hind- or midfoot OA

  • Informed consent

  • Age ≥ 18 years

  • Average NRS ≥4 in rest 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Martini Hospital Groningen Netherlands 9728 NT

Sponsors and Collaborators

  • Martini Hospital Groningen

Investigators

  • Principal Investigator: Tom van Raaij, MD/PhD, Martini Ziekenhuis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Arthur van Hasselt, drs. A.J. van Hasselt, Martini Hospital Groningen
ClinicalTrials.gov Identifier:
NCT05912153
Other Study ID Numbers:
  • ProSPECT study
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arthur van Hasselt, drs. A.J. van Hasselt, Martini Hospital Groningen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023