Can EOS Hip Imaging Replace CT Hip Scans?

NCT05921721 | Unknown

• 1 other identifier: SCH-2653
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The orientation of the femoral neck in relation to the coronal or transcondylar axis of the distal femur is known as the femoral version. It is categorised as femoral anteversion when the femoral neck axis is anteriorly rotated in relation to transcondylar axis, while femoral head axis is anterior in relation to the femur coronal plane; or femoral retroversion when the femoral head-neck axis points are posterior to the femoral coronal plane. Some studies suggest that conventional radiography cannot adequately measure femoral version, and should be avoided in favour of more precise methods using computed tomography (CT) scanning. CT imaging is currently the reference method for measuring femoral version. However, its clinical use is limited by issues such as high levels of radiation exposure, which can adversely affect patients, especially children. Magnetic resonance imaging (MRI) is considered an alternative for measuring femoral version; however, it is expensive, time consuming and subject to motion artifacts. The associated costs and risks of MRI increase when anaesthesia is needed for the examination. The EOS imaging system could provide an alternative to the previously mentioned techniques. It uses lower doses of irradiation and the sterEOS software allows the production of 3D images. This study aims to compare the accuracy of the EOS imaging system with CT for the measurement of hip parameters in individuals aged 13 years and older. In addition, this study aims to correlate EOS and CT parameters with gait analysis and compare the ability of EOS and CT to predict gait abnormalities.

Conditions

Femoroacetabular Impingement; Hip Dysplasia

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of EOS

  Diagnostic accuracy of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older

  18 months

• Inter- and intraobserver reliability of EOS

  Inter- and intraobserver reliability of the EOS imaging system compared to CT for measuring native hip/pelvic parameters in individuals aged 13 years and older

  18 months

Secondary Outcomes (1)

• Predictive power of EOS

  18 months

Study Arms (1)

EOS imaging system

EXPERIMENTAL

Participants will undergo CT and EOS imaging pre- and post- operatively. The EOS is being compared to the reference method CT scan.

Device: EOS

Interventions

EOS DEVICE

This modality simultaneously captures biplanar radiographs (anteroposterior and lateral images) through the whole-body slot scanning with patients in standing position with ultralow irradiation

EOS imaging system

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals aged 13 years and older who are considered eligible to undergo periacetabular osteotomy (PAO).
• Symptomatic dysplasia (Severin grade II or III) or femoroacetabular impingement.
• Skeletal maturity, defined on pelvic radiographs by closure of the triradiate cartilage.
• Absence of subluxation (Severin grade I-III).

You may not qualify if:

• Obvious joint incongruency.
• Loss of sphericity (Severin IV or above).
• Evidence of moderate or severe arthritis (Tonnis 2 or above).

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead
• EOS imaging Inc.: collaborator

MeSH Terms

Conditions

Femoracetabular Impingement; Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Wounds and Injuries; Hip Injuries

Study Officials

• Amaka Offiah

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Dimtri

CONTACT

0114 2717000; paul.dimitri@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share