Osteoarthritis, KneeVISCODIAGNCT04931121
EVALUATION OF THE CAPACITY OF A BIOMARKER BASED ON THE RAMAN ANALYSIS OF SYNOVIAL FLUID
An observational study of Osteoarthritis, Knee, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Viscosupplements
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 27 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
GRANGE Laurent, PH, +33 (0)4 76 76 51 36, lgrange@chu-grenoble.fr
GRUEL Réjane, +33 (0)4 76 76 72.23, rgruel@chu-grenoble.fr
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Viscosupplements
- Keywords
- Osteoarthritis, Synovial fluid, Raman spectroscopy, Viscosupplementation, Biomarkers
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViscosupplementsDrug
Synovial fluid is collected as part of a conventional injection of viscosupplement
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritic patients | Subjects are patients referred for knee osteoarthritis and treated with an hyaluronic acid injection (viscosupplementation) Receives: Drug: Viscosupplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start28 Aug 2018
- Primary completion27 Aug 2021 (estimated)
- Study completion27 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GRANGE Laurent, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931121
- Sponsor's protocol ID
- 38RC17.414
- Other IDs
- 2017-A03663-50
- Acronym
- VISCODIAG
- Status last verified
- Jun 2021
- First submitted
- 12 May 2020
- Last updated
- 18 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04931121
- Acronym / sponsor ID
- VISCODIAG / 38RC17.414
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Synovial fluid, Raman spectroscopy, Viscosupplementation, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 27 Aug 2021 (estimated)
- Study completion
- 27 Aug 2021 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritic patients | – | Drug: ViscosupplementsSubjects are patients referred for knee osteoarthritis and treated with an hyaluronic acid injection (viscosupplementation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViscosupplementsSynovial fluid is collected as part of a conventional injection of viscosupplement | Drug | Osteoarthritic patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GRANGE Laurent principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GRANGE Laurent (+33 (0)4 76 76 51 36, lgrange@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers analysis based on Raman analysis of synovial fluid (SF) (SYNODIAG) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.