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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT04931121

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Viscosupplements

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 Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 28, 2018

Anticipated Primary Completion Date :

Aug 27, 2021

Anticipated Study Completion Date :

Aug 27, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Osteoarthritic patients

Subjects are patients referred for knee osteoarthritis and treated with an hyaluronic acid injection (viscosupplementation)

Drug: Viscosupplements

Synovial fluid is collected as part of a conventional injection of viscosupplement

Outcome Measures

Primary Outcome Measures

Biomarkers analysis based on Raman analysis of synovial fluid (SF) (SYNODIAG) [6 months]
Measuring the physicochemical index of the dried drop of SF (Raman ratios) between responding and non-responding patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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