Knee OsteoarthritisART-QUALIVIENCT02840422
Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections
An observational study of Knee Osteoarthritis, run by LCA Pharmaceutical.
Trial summary
The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ARTHRUM H 2%
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2016to 28 Jul 2017
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or Women aged aver 40 ans suffering fromm knee osteoarthritis
Who may be able to join
- Men or women aged over 40;
- Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale
- Patient able to understand the trial procedure and give his/her consent to take part, in writing;
- Patient geographically stable during the trial;
- Patient affiliated to the French social security regime or benefiting from such a French regime.
Who cannot join
- Inflammatory arthritis;
- Progressive infectious condition of the knee being studied;
- Previous treatment with viscosupplementation for at least one year;
- Injection of corticoids into the knee studied for less than two months;
- Known hypersensivity to hyaluronic acid or substances with similar activity;
- Pregnant or breast-feeding women;
- Patient under guardianship or tutorship or under juridicial protection;
- Patient currently taking part in another clinical research study.
About this study
Official title: Assessment of Patients Quality of Life Suffering From Knee Osteoarthritis Treated With Three Intra-articular Injections of ARTHRUM H 2% Over a Period of Six Months
The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.
This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.
Read the detailed description
Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)
- Conditions
- Knee Osteoarthritis
- Being tested
- ARTHRUM H 2%
- Keywords
- Hyaluronic acid, Knee osteoarthritis, Quality of life
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTHRUM H 2%Device
ARTHRUM H 2%
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial)
Measured: 6 months
Secondary outcomes (3)
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)
- From D0 to D90
- From D90 to D180
Measured: 6 months
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)
- From D0 to D90
- From D0 to D180
- From D90 to D180
Measured: 6 months
To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)
- From D0 to D90
- From D0 to D180
- From D90 to D180
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 posted21 Jul 2016 (estimated)
- Study start3 Feb 2016
- Primary completion8 Dec 2016
- Study completion28 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- LCA Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CHRISTIAN PASCARETTI, MD, Study director, Le Ronceray RhumatologiePaolo INSALACO, MD, Study director, Le Ronceray RhumatologieANTOINE LESORT, MD, Study chair, Hopital Prive des Peupliers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840422
- Sponsor's protocol ID
- 140515
- Acronym
- ART-QUALIVIE
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients Quality of Life Suffering From Knee Osteoarthritis Treated With Three Intra-articular Injections of ARTHRUM H 2% Over a Period of Six Months
- ClinicalTrials.gov ID
- NCT02840422
- Acronym / sponsor ID
- ART-QUALIVIE / 140515
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic acid, Knee osteoarthritis, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- LCA PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials.
This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.
Detailed description
Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or Women aged aver 40 ans suffering fromm knee osteoarthritis
Key inclusion criteria (5 listed)
- Men or women aged over 40;
- Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale
- Patient able to understand the trial procedure and give his/her consent to take part, in writing;
- Patient geographically stable during the trial;
- Patient affiliated to the French social security regime or benefiting from such a French regime.
Key exclusion criteria (8 listed)
- Inflammatory arthritis;
- Progressive infectious condition of the knee being studied;
- Previous treatment with viscosupplementation for at least one year;
- Injection of corticoids into the knee studied for less than two months;
- Known hypersensivity to hyaluronic acid or substances with similar activity;
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 |
|---|---|---|
| ARTHRUM H 2%ARTHRUM H 2% | Device | – |
Primary outcome
To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial)
Time frame: 6 months
3 secondary outcomes
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)
Time frame: 6 months
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)
Time frame: 6 months
To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
CHRISTIAN PASCARETTI, MD study director
Le Ronceray Rhumatologie
Paolo INSALACO, MD study director
Le Ronceray Rhumatologie
ANTOINE LESORT, MD study chair
Hopital Prive des Peupliers
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by LCA Pharmaceutical.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial) (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 19 Jan 2024.