Diagnostic Performance of Ultrasound Imaging Technique for Femoral Condyle Cartilage Evaluation and Osteoarthritis

NCT03184051 | Completed

• 1 other identifier: 38RC17.074
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Ultrasonography evaluation/ultrasound; Articular cartilage; UltraSound Speed Of Sound (US-SOS); UltraSound Time of Flight (US-TOF)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the correlation between the Time of Flight (TOF) of ultrasounds between the two interfaces (bone / cartilage and cartilage / water) and the real thickness of the cartilage measured by Magnetic Resonance Imaging (MRI).

  Correlation coefficients between US-TOF measurements and cartilage thickness measurements corresponding to MRI.

  5 months

Secondary Outcomes (3)

• Evaluation of the relationship between the propagation velocity of the ultrasound wave in cartilage tissue and the osteoarthritis degree defined by OARSI scale.

  5 months

• Evaluation of the relationship between 3D surface reconstruction and defects of cartilage samples from localized ultrasound data and those derived from MRI data

  5 months

• Evaluation of correlation between thickness measured by MRI and this measured by histological analysis.

  5 months

Study Arms (1)

Ultrasound assessment

All subject of the study have a knee osteoarthritis (OA) and are going to have a total arthroplasty. Diagnostic performance of ultrasonography is evaluated on ex vivo cartilage samples (2 samples per patient are selected with different stage of OA : 1 with early stage and 1 with advanced stage).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with knee osteoarthritis with an indication of total arthroplasty

You may qualify if:

• patient over 18 year old
• knee osteoarthritis which total knee arthroplasty indication
• who have signed a non-objection form.

You may not qualify if:

• person who refuse to sign a non-objection form
• person deprived of liberty by judicial or administrative decision
• person under legal protection or unable to express their consent
• person hospitalized for psychiatric care

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• TIMC-IMAG: collaborator
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (1)

Orthopedic Surgery Department, University Hospital, Grenoble

Grenoble, 38043, France

Location

Related Links

• Description: Clinical Investigation Centre for Innovative Technology Network website

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alexandre Moreau -Gaudry, MD, PhD

  Clinical Investigation Centre for Innovative Technology Network - University Hospital Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: June 15, 2017
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)