Knee OsteoarthritisART-ONE75NCT06228274
Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee
An observational study of Knee Osteoarthritis, run by LCA Pharmaceutical.
Trial summary
ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis. The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered… 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 2.5%
- Type of treatment
- Medical device
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 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 over 40 * Suffering from knee osteoarthritis
Who may be able to join
- Men or women aged over 40
- Suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months
- 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 three months
- Known hypersensitivity to hyaluronic acid or substances with similar activity
- Anticoagulant treatment in progress
Show all 10Show fewer
- Insulin-dependent / type I diabetes
- Pregnant or breast-feeding women
- Patient under guardianship or tutorship or under judicial protection
- Patient currently taking part in another clinical research study.
About this study
Official title: Measurement of the Real Life Efficacy of ARTHRUM 2.5% Health Product Single Injection in Patients Suffering From Knee Osteoarthritis
ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.
The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from Knee osteoarthritis
Read the detailed description
Parameters used to determine treatment outcomes include: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC Index), Evaluation of Quality of Life and Handicap and Assessment of therapeutic efficacy
- Conditions
- Knee Osteoarthritis
- Being tested
- ARTHRUM 2.5%
- Keywords
- Hyaluronic Acid, Knee Osteoarthritis
- 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 2.5%Device
ARTHRUM 2.5%
| Study group | Role | What they receive |
|---|---|---|
| ARTHRUM 2.5% single injection | Not described Receives: Device: ARTHRUM 2.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels
Measured: 6 months
Secondary outcomes (5)
Safety of ARTHRUM 2.5% under actual conditions of prescription and use: frequency, nature and severity of reported side effects assessed by Likert scale on four levels
Measured: 6 months
Reduction of consumption of Analgesics and NSAIDs after ARTHRUM 2.5% intra-articular injection assessed by Likert scale on four levels.
Measured: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's activity assessed by Likert scale on five levels
Measured: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's quality of life by responding one questionnaire assessed by Likert scale on six levels
Measured: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's handicap level by responding one questionnaire assessed by Likert scale on five levels
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 posted29 Jan 2024
- Study startMar 2013
- Primary completionSep 2015
- Study completionMar 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- LCA Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BIOSTATEM
- Responsible party
- Sponsor
- Investigators
- DOMINIQUE BARON, MD, Study director, Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228274
- Sponsor's protocol ID
- 131001
- Acronym
- ART-ONE75
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2016
- Last updated
- 29 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Real Life Efficacy of ARTHRUM 2.5% Health Product Single Injection in Patients Suffering From Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06228274
- Acronym / sponsor ID
- ART-ONE75 / 131001
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic Acid, Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- LCA PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- BIOSTATEM
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Jan 2024 (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.
ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.
The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.
This prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from Knee osteoarthritis
Detailed description
Parameters used to determine treatment outcomes include: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC Index), Evaluation of Quality of Life and Handicap and Assessment of therapeutic efficacy
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARTHRUM 2.5% single injection | – | Device: ARTHRUM 2.5% |
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 over 40 * Suffering from knee osteoarthritis
Key inclusion criteria (5 listed)
- Men or women aged over 40
- Suffering from unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months
- 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 (10 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 three months
- Known hypersensitivity 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 2.5%ARTHRUM 2.5% | Device | ARTHRUM 2.5% single injection |
Primary outcome
Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels
Time frame: 6 months
5 secondary outcomes
Safety of ARTHRUM 2.5% under actual conditions of prescription and use: frequency, nature and severity of reported side effects assessed by Likert scale on four levels
Time frame: 6 months
Reduction of consumption of Analgesics and NSAIDs after ARTHRUM 2.5% intra-articular injection assessed by Likert scale on four levels.
Time frame: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's activity assessed by Likert scale on five levels
Time frame: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's quality of life by responding one questionnaire assessed by Likert scale on six levels
Time frame: 6 months
Study of ARTHRUM 2.5% intra-articular impact on the Patient's handicap level by responding one questionnaire assessed by Likert scale on five levels
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 29 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.
DOMINIQUE BARON, MD study director
Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel
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 10 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 29 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?
Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels (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 29 Jan 2024.