NCT04863911

Brief Summary

The aim of this work is to compare the role of CT hip arthrography to MR arthrography in the detection of intra-articular hip pathology.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

April 24, 2021

Last Update Submit

September 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Sensitivity refers to true positive rate, the percentage of patients with actual illness who was correctly diagnosed in overall patients by each of CT arthrography and MRI arthrography. High sensitivity indicated high correct rate in diagnosis of intra-articular hip pathology.

    1 week

Secondary Outcomes (3)

  • Specificity

    1 week

  • positive predictive value

    1 week

  • Negative predictive value

    1 week

Interventions

1 mL of gadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) will be diluted with 100 mL of saline; 8 mL of this will be mixed with 7 mL of iodine solution (340 mg/cc) and 3 mL of lidocaine 2% and injected under ultrasonographic guidance. The fixed US-guided technique, the needle will be inserted into the needle guide hole and directed toward the hip joint, targeting the femoral head-neck junction. The volume injected varies from 10 to 20 mL, with a mean of 15 mL. Ideally CT should be performed immediately after the injection and MR should be performed within 90 minutes after the initial injection.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of different sex and age groups presenting to the Radiology department with clinical and routine imaging suggestive of intraarticular hip pathology.

You may qualify if:

  • consecutive patients presenting with clinical and routine imaging suggestive of intraarticular hip pathology.
  • patients must be accept the intraarticular hip injection of contrast.

You may not qualify if:

  • Any general contraindication of MRI in some cases as presence of anti-paramagnetic substance as pacemakers aneurysm clips, metallic cochlear implants
  • Severely ill patients or those with claustrophobia
  • Any general contraindications to radiation in some cases such as pregnancy at first trimester.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Llopis E, Fernandez E, Cerezal L. MR and CT arthrography of the hip. Semin Musculoskelet Radiol. 2012 Feb;16(1):42-56. doi: 10.1055/s-0032-1304300. Epub 2012 Mar 23.

  • Perdikakis E, Karachalios T, Katonis P, Karantanas A. Comparison of MR-arthrography and MDCT-arthrography for detection of labral and articular cartilage hip pathology. Skeletal Radiol. 2011 Nov;40(11):1441-7. doi: 10.1007/s00256-011-1111-9. Epub 2011 Feb 6.

  • Schneider G, Massmann A, Fries P, Kusma M, Dienst M. [Magnetic resonance tomography and arthrography of the hip joint]. Orthopade. 2006 Jan;35(1):22-6, 28-32. doi: 10.1007/s00132-005-0890-x. German.

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ehab Mohammad, A. Professor

    Diagnostic radiology department Assiut university hospital

    STUDY DIRECTOR
  • Noha Attia, Lecturer

    Diagnostic radiology department Assiut university hospital

    STUDY DIRECTOR

Central Study Contacts

Nafisa Hussein, specialist

CONTACT

Samy Khalil, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist of radiology Assuit University Hospitals

Study Record Dates

First Submitted

April 24, 2021

First Posted

April 28, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

September 27, 2021

Record last verified: 2021-09