Knee OsteoarthritisNCT01543737
Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
A study testing 3ml hyaluronic acid (DUROLANE) and 2ml hyaluronic acid, (HYALGAN) in people with Knee Osteoarthritis, run by Bioventus LLC at 17 sites in 2 countries.
Trial summary
The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- 3ml hyaluronic acid (DUROLANE) and 2ml hyaluronic acid, (HYALGAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Feb 2012to Feb 2014
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 and < 85
- Tibiofemoral osteoarthritis of the knee according to the American College of Rheumatology clinical criteria, in the Kellgren-Lawrence (KL) stages II-III, confirmed by radiology (< 3 months)
- Unilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed over the previous 24 hours on a scale of 0 to 10: Pain when walking: ≤ 3 and < 8
- Bilateral osteoarthritis of the knee, if pain in the other knee is < 3 (10-point numerical scale)
- Patient: outpatient, capable of walking 50 metres without a walking stick, crutches or a walker, capable of reading, understanding, signing and dating the patient information sheet
- Patient with social security cover
Who cannot join
- Osteoarthritis of the knee in Kellgren-Lawrence (KL) stages I and IV
- Bilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed on a scale of 0 to 10: Pain when walking > 3, in both knees
- Predominant symptomatic patellofemoral osteoarthritis of the knee
- Congestive manifestation of osteoarthritis of the knee defined according to the Knee Osteoarthritis Flare-Ups Score (KOFUS) criteria
- Last viscosupplementation of the affected knee < 6 months before, last injection of corticosteroids < 2 months before
- Known hypersensitivity to avian proteins and hyaluronic acids;
Show all 24Show fewer
- History of joint replacement or major surgery in the affected knee in the last six months
- History of arthroscopy or surgery in the affected knee in the last three months
- Symptomatic hip disease on the same side or other side of the body
- Joint replacement or any other surgery planned in the next six months
- History of septic arthritis of the affected knee
- Skin complaint affecting the knee at the injection site
- Haemorrhagic disease contraindicating, in the doctor's opinion, any intra-articular injection
- In order to respect the pragmatic nature of the study:
- Any medical and / or pathological condition that, in the investigator's opinion, makes the subject unsuitable for inclusion
- Any medical and / or pathological condition that, in the investigator's opinion, would be a contraindication for an intra-articular injection
- Any other complaint that, in the investigator's opinion, would impede the assessment of the effectiveness of the affected knee
- Any treatment administered to the patient that may interfere with the interpretation of the study results
- Use of glucocorticosteroids (except inhaled corticosteroids) during the previous month
- Treatment with diacerein, avocado and soya unsaponifiables, glucosamine sulphate or chondroitin sulphate, started in the previous 3 months, or irregular doses over the previous 3 months
- Hard of hearing (not being able to follow a telephone conversation properly)
- Patient without a telephone
- Pregnant women or nursing mothers
- Participation in other clinical studies, within 30 days before inclusion
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
France16 sites
Cabinet Médical
Argeles
Centre Hospitalier de Belfort-Montbeliard
Belfort
Cabinet Médical
Billère
Cabinet Médical
Cabestany
Cabinet Médical Cabinet Médical
Cornebarrieu
Chu Henri Mondor
Créteil
Cabinet Médical
Lyon
Cabinet Médical
Metz
Hopital de Meulan-les-Mureaux
Meulan-en-Yvelines
Polyclinique Saint Odilon
Moulins
Centre Médical Europe
Paris
Institut de l'Appareil Locomoteur - Nollet
Paris
Hopitaux de Saint Marice
Saint-Maurice
Cabinet Médical
Strasbourg
Cabinet Medical
Valence
Cabinet Médical
Villeurbanne
About this study
Official title: Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
Read the detailed description
non-inferiority study of two HA products commercially availalble
- Conditions
- Knee Osteoarthritis
- Being tested
- 3ml hyaluronic acid (DUROLANE), 2ml hyaluronic acid, (HYALGAN)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3ml hyaluronic acid (DUROLANE)Device
DUROLANE Hyaluronic acid 20mg/ml
2ml hyaluronic acid, (HYALGAN)Device
HYALGAN Hyaluronic acid 10mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Single injection hyaluronic acid | Active comparator | 3ml hyaluronic acid (DUROLANE) Receives: Device: 3ml hyaluronic acid (DUROLANE) |
| Three injection hyaluronic acid | Active comparator | 2ml hyaluronic acid (HYALGAN) Receives: Device: 2ml hyaluronic acid, (HYALGAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients assessment of WOMAC A1 pain when walking
Measured: 24 weeks
Secondary outcomes (7)
Patients assessment of WOMAC A pain
Measured: 24 weeks
Patients assessment of WOMAC C function
Measured: 24 weeks
Patient global assessment
Measured: 24 weeks
OMERACT-OARSI responder rate
Measured: 24 weeks
Patient Acceptable Symptom State (PASS)
Measured: 24 weeks
Minimal Clinically Important Improvement (MCII)
Measured: 24 weeks
Adverse events observed or spontaneously reported by patients for each treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: post transfer of company ownership from Smith \& Nephew to Bioventus LLC
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Conrozier, MD, Principal investigator, Lyon University Hospital (HCL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543737
- Sponsor's protocol ID
- SNOF EC 01/2010
- Status last verified
- Feb 2016
- First submitted
- 20 Feb 2012
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT01543737
- Acronym / sponsor ID
- SNOF EC 01/2010
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: post transfer of company ownership from Smith \& Nephew to Bioventus LLC
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 2012 (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 purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
Detailed description
non-inferiority study of two HA products commercially availalble
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single injection hyaluronic acid | Active comparator | Device: 3ml hyaluronic acid (DUROLANE)3ml hyaluronic acid (DUROLANE) |
| Three injection hyaluronic acid | Active comparator | Device: 2ml hyaluronic acid, (HYALGAN)2ml hyaluronic acid (HYALGAN) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 and < 85
- Tibiofemoral osteoarthritis of the knee according to the American College of Rheumatology clinical criteria, in the Kellgren-Lawrence (KL) stages II-III, confirmed by radiology (< 3 months)
- Unilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed over the previous 24 hours on a scale of 0 to 10: Pain when walking: ≤ 3 and < 8
- Bilateral osteoarthritis of the knee, if pain in the other knee is < 3 (10-point numerical scale)
- Patient: outpatient, capable of walking 50 metres without a walking stick, crutches or a walker, capable of reading, understanding, signing and dating the patient information sheet
Key exclusion criteria (24 listed)
- Osteoarthritis of the knee in Kellgren-Lawrence (KL) stages I and IV
- Bilateral symptomatic osteoarthritis of the knee causing pain when walking (WOMAC A1 scale), assessed on a scale of 0 to 10: Pain when walking > 3, in both knees
- Predominant symptomatic patellofemoral osteoarthritis of the knee
- Congestive manifestation of osteoarthritis of the knee defined according to the Knee Osteoarthritis Flare-Ups Score (KOFUS) criteria
- Last viscosupplementation of the affected knee < 6 months before, last injection of corticosteroids < 2 months before
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 |
|---|---|---|
| 3ml hyaluronic acid (DUROLANE)DUROLANE Hyaluronic acid 20mg/ml | Device | Single injection hyaluronic acid |
| 2ml hyaluronic acid, (HYALGAN)HYALGAN Hyaluronic acid 10mg/ml | Device | Three injection hyaluronic acid |
Primary outcome
Patients assessment of WOMAC A1 pain when walking
Time frame: 24 weeks
7 secondary outcomes
Patients assessment of WOMAC A pain
Time frame: 24 weeks
Patients assessment of WOMAC C function
Time frame: 24 weeks
Patient global assessment
Time frame: 24 weeks
OMERACT-OARSI responder rate
Time frame: 24 weeks
Patient Acceptable Symptom State (PASS)
Time frame: 24 weeks
Minimal Clinically Important Improvement (MCII)
Time frame: 24 weeks
Adverse events observed or spontaneously reported by patients for each treatment
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: post transfer of company ownership from Smith \& Nephew to Bioventus LLC). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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.
Thierry Conrozier, MD principal investigator
Lyon University Hospital (HCL)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3ml hyaluronic acid (DUROLANE) and 2ml hyaluronic acid, (HYALGAN) in people with Knee Osteoarthritis, run by Bioventus LLC at 17 sites in 2 countries.
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 6 inclusion and 24 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: stopped early, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Monaco. 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?
The study was stopped early (reason given: post transfer of company ownership from Smith \& Nephew to Bioventus LLC). Results are not available in the source record.
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?
Patients assessment of WOMAC A1 pain when walking (time frame: 24 weeks). 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 12 Feb 2016.