EVALUATION OF THE CAPACITY OF A BIOMARKER BASED ON THE RAMAN ANALYSIS OF SYNOVIAL FLUID (VISCODIAG)

June 17, 2021 updated by: University Hospital, Grenoble

EVALUATION OF THE CAPACITY OF A BIOMARKER BASED ON THE RAMAN ANALYSIS OF SYNOVIAL FLUID TO IDENTIFY ARTHROSIC PATIENTS RESPONDING TO VISCOSUPPLEMENTATION / VISCODIAG

Osteoarthritis (OA) is the most common joint disease in the world and induces major physical, psychological, societal and economic burdens.

The management of osteoarthritis is complex. Viscosupplementation by local injection in the arthritic knee is a validated therapy used after failure of conventional analgesic treatments and non-pharmacological modalities. The size effect of this treatment is modest between 0.3 and 0.6. We do not currently have any predictive criteria for the effectiveness of this treatment.

The procedure tested in this research is the characterization of synovial fluid (SF) by an in vitro Raman microspectroscopy technique.

The results obtained will make it possible to compare the effectiveness of visco-supplementation with hyaluronic acid from the Hyalgan© trade according to classic criteria in the literature.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The proposed study consists in analysing the synovial fluid (SF) of patients obtained in conventional care that do not require new medical or nursing procedures.

All care that patients will receive is routinely provided by physicians. There is no additional act of surveillance during the research. The follow-up medical visits are exactly the same as those offered to patients as part of their treatment, no additional visits are required.

During the orthopedic consultation for HA injection, the initial WOMAC score as well as the PGAP and PASS scores will be measured. SF, usually considered as medical waste, will be collected during an arthrocentesis prior to the intra-articular injection of hyaluronic acid, freezed at -80°C and then sended to the IVTV platform at the Ecole Centrale de Lyon for DDRS Raman spectroscopy (LabRam HR 800, Horiba Jobin Yvon, Villeneuve d'Asq). Studied SYNODIAG biomarkers are dried drops parameters (surface) and Raman ratios according to the FR3059781 patent.

At the 6-month follow-up visit, WOMAC, PGAP and PASS scores will be re-measured to determine the patient's responding/non-responding status.

Finally, the objective of the study is to verify if there are significant differences between the Raman ratios and dried drops parameters of SF patients responding and non-responding to viscosupplementation.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects are patients referred for knee osteoarthritis and treated with an hyaluronic acid injection (viscosupplementation). The patient knee radiography will be used to grade osteoarthritis according to the Kellgren Lawrence score. The study will be limited to patients with a KL score lower than 4.

Description

Inclusion Criteria:

  • If woman, not to be pregnant
  • Have radiographically diagnosed osteoarthritis of the knee that meets OARSI criteria for gonarthrosis (Altman and Gold, 2007; Kellgren and Lawrence, 1957).
  • Present a Kellgren-Lawrence radiographic score lower than 4
  • Be treated with visco-supplementation after failure of conventional analgesic treatments and non-pharmacological modalities.

Exclusion Criteria:

  • BMI greater than 28
  • BMI lower than 15
  • Kellgren-Lawrence score of 4
  • Patients with no clinical symptoms of osteoarthritis
  • Patients treated with intra-articular steroid injection during follow-up
  • Patients who have had a synovectomy
  • Patients with severe systemic disease or with rheumatoid arthritis or other intercurrent rheumatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteoarthritic patients
Subjects are patients referred for knee osteoarthritis and treated with an hyaluronic acid injection (viscosupplementation)
Synovial fluid is collected as part of a conventional injection of viscosupplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers analysis based on Raman analysis of synovial fluid (SF) (SYNODIAG)
Time Frame: 6 months
Measuring the physicochemical index of the dried drop of SF (Raman ratios) between responding and non-responding patients.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: GRANGE Laurent, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Anticipated)

August 27, 2021

Study Completion (Anticipated)

August 27, 2021

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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