NCT03210584

Brief Summary

Evaluation and comparison of histological analysis, 9,4 tesla MRI, Full-Field Optical Coherence Tomography (FFOCT) and ultrasound-based navigation system for cartilage degeneration analysis of patellofemoral joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

June 6, 2017

Last Update Submit

September 10, 2018

Conditions

Knee Osteoarthritis

Keywords

Knee jointCartilage degenerationUltrasound imagingFull-Field Optical Coherence Tomography9,4 Tesla MRIMultimodal evaluation

Outcome Measures

Primary Outcomes (1)

  • Evaluation and comparison of histologic analysis, 9,4 Tesla MRI, FFOCT and ultrasound-based navigation system for cartilage lesions analysis of patellofemoral joint.

    Correlation between Osteoarthritis Research Society International (OARSI) grades performed for different modalities

    6 months

Secondary Outcomes (9)

  • Evaluation of 9,4 Tesla MRI reconstructions in early osteoarthritis evaluation using visual qualitative information parameter obtained from the Average Pathlength Maps (APM).

    6 months

  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual qualitative information parameter.

    6 months

  • Evaluation of navigation ultrasound in early osteoarthritis evaluation using visual qualitative information parameter.

    6 months

  • Evaluation of of 9,4 Tesla MRI reconstruction in early osteoarthritis evaluation using visual quantitative information parameter obtained for the Average Pathlength Maps.

    6 months

  • Evaluation of FFOCT reconstructions in early osteoarthritis evaluation using visual quantitative information parameter.

    6 months

  • +4 more secondary outcomes

Study Arms (1)

Imaging measurements

All subject of the study have a knee osteoarthritis (OA) and are going to have a knee prosthetic surgery with cartilage excision. Multimodal evaluation is conducted on ex vivo human cartilage samples (2 samples per patient are selected : healthy and severely degraded).

Eligibility Criteria

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

Patients with knee arthroplasty indication for medial femoro-tibial osteoarthristis at University Hospital, Grenoble

You may qualify if:

  • Over 18 years of age
  • Knee prosthetic surgery indication with cartilage excision.

You may not qualify if:

  • Subjects who refuse to sign a non-objection form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Surgery Department, University Grenoble Hospital

Grenoble, 38043, France

Location

Related Links

Biospecimen

Retention: NONE RETAINED

cartilage samples undergoing total knee arthroplasty procedure

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Alexandre Moreau-Gaudry, MD, PhD

    Clinical Investigation Centre for Innovative Technology Network

    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 6, 2017

First Posted

July 7, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

September 1, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)