NCT04931121

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 28, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

May 12, 2020

Last Update Submit

June 17, 2021

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisSynovial fluidRaman spectroscopyViscosupplementationBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Biomarkers analysis based on Raman analysis of synovial fluid (SF) (SYNODIAG)

    Measuring the physicochemical index of the dried drop of SF (Raman ratios) between responding and non-responding patients.

    6 months

Study Arms (1)

Osteoarthritic patients

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

Drug: Viscosupplements

Interventions

ViscosupplementsDRUG

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

Osteoarthritic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Viscosupplements

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Protective AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of ChemicalsViscoelastic Substances

Study Officials

  • GRANGE Laurent

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GRANGE Laurent

CONTACT

+33 (0)4 76 76 51 36lgrange@chu-grenoble.fr

GRUEL Réjane

CONTACT

+33 (0)4 76 76 72.23rgruel@chu-grenoble.fr

Study Design

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

Study Record Dates

First Submitted

May 12, 2020

First Posted

June 18, 2021

Study Start

August 28, 2018

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

FR(1)