Knee OsteoarthritisNCT03203408

Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis

A study testing OSTENIL PLUS and SYNVISC-ONE in people with Knee Osteoarthritis, run by TRB Chemedica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of the study was to demonstrate the non-inferiority of the efficacy of a single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral osteoarthritis. 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?: OSTENIL PLUS and SYNVISC-ONE
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 290 participants
Where: No sites listed yet
Study dates: 21 Jun 2011to 22 Nov 2012
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

Male or female aged 40-85 years;
Primary knee osteoarthritis complying with the American College or Rheumatology criteria;
Radiographically defined osteoarthritis: joint space narrowing and osteophyte in X-ray taken less than one year previously and modified Kellgren-Lawrence grade Ib-III;
Symptoms on one side only, with a mean WOMAC A of ≥40 mm. If knee osteoarthritis is bilateral, a difference for that score between the contralateral knee and the selected knee should be of at least 20 mm;
Pain present on at least 15 days in the month before inclusion;
Failure or intolerance of first line analgesics and NSAIDs;

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With health insurance;
Understanding and following the study instructions;
Signed the informed consent.

Who cannot join

Knee osteoarthritis that is not symptomatic or insufficiently symptomatic;
Bilateral symptomatic knee osteoarthritis of the same severity on both sides;
Post-traumatic secondary knee osteoarthritis;
Knee osteoarthritis of radiographic grade I, Ia or IV;
Exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (Patellar syndrome);
Symptomatic homolateral coxarthrosis;

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Varus or valgus deformation of the selected knee (deformation axis ≥15° in X-ray);
Inflammatory rheumatism (rheumatoid arthritis, psoriatic rheumatism, articular chondrocalcinosis, gout, Paget's disease, ankylosing spondylitis, lupus, etc.);
History of injury to the selected knee during the 6 months before inclusion;
Venous or lymphatic stenosis of the lower limb;
Femoral or sciatic nerve root pain of the lower limb to be tested;
Tendinopathy (e.g. hip periarthritis);
Treatment with intra-articular hyaluronic acid in the selected knee during the 6 months before inclusion;
Intra-articular injection of corticosteroids in the selected knee during the 2 months before inclusion;
Treatment with symptomatic slow-acting drugs for osteoarthritis and/or dietary supplements for osteoarthritis (chondroitin sulphate, diacerein, avocado and soybean unsaponifiables, oxaceprol, copper granions, glucosamine) which had been started less than 3 months previously or whose dose had been changed during the last 3 months before inclusion;
Total knee replacement of the selected knee;
Surgery of the other knee or of the hip or any other surgery scheduled during the period of the study;
History of any surgical intervention, arthroscopy, osteotomy, etc. in the year before inclusion;
Obesity: body mass index ≥30 kg/m2;
History of autoimmune disease;
Severe condition likely to interfere with the evaluation, such as neoplasia, malignant blood disease, kidney disease, liver disease or severe infection;
Very marked hydrarthrosis (requiring puncture) at the time of inclusion;
Wound or skin condition of the selected knee;
Anticoagulant treatment with heparin or warfarin (platelet antiaggregants such as ASPIRIN ≤325 mg/d, ticlopidine or clopidogrel were allowed);
Known hypersensitivity to hyaluronic acid and/or to avian proteins and/or paracetamol;
Known hypersensitivity to mannitol;
Participation in a clinical research study within the previous 3 months;
Pregnancy, breast-feeding.

About this study

Official title: Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis. A Randomised, Controlled, Double-blind, Parallel-group Study With a 6-month Follow-up

Read the detailed description

After a period of washout-out for NSAIDs, the patients received a single intra-articular injection of OSTENIL PLUS or of SYNVISC-ONE in the most painful knee. The study involved a preselection visit at D-7 and five further visits: at D0 (baseline, evaluation before intra-articular injection), at D2 ± 2 days (injection), at D30 ± 15 days, at D90 ± 15 days and C5 at D180 ± 15 days.

To enrol the patients as quickly as possible, 129 sites, i.e. general medical or rheumatology practices, were open. After verifying the inclusion and exclusion criteria, the evaluating investigators assigned a randomisation number based on the chronological order of inclusion of patients at their site. The patient was then sent to the injecting investigator so that he/she could give the injection of the product corresponding to the randomisation number.

Conditions: Knee Osteoarthritis
Being tested: OSTENIL PLUS, SYNVISC-ONE
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OSTENIL PLUSDevice
Injection into the joint cavity of the most painful knee
SYNVISC-ONEDevice
Injection into the joint cavity of the most painful knee

Study groups in NCT03203408
Study group	Role	What they receive
OSTENIL PLUS	Experimental	A single intra-articular injection of sodium hyaluronate 40 mg/2.0 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0) Receives: Device: OSTENIL PLUS
SYNVISC-ONE	Active comparator	A single intra-articular injection of hylan G-F 20 48 mg/6 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0) Receives: Device: SYNVISC-ONE

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in WOMAC A
Change from baseline in the pain subscore (section A) of the WOMAC score
Measured: Day 0 to Day 180

Secondary outcomes (6)

Lequesne algofunctional index
Index assessing the severity of osteoarthritis
Measured: Day 0 to Day 180
WOMAC B
Stiffness subscore (section B) of the WOMAC score
Measured: Day 0 to Day 180
WOMAC C
Function subscore (section C) of the WOMAC score
Measured: Day 0 to Day 180
Patient's overall status score in relation to his/her knee osteoarthritis
Visual analogue scale assessed by the patient
Measured: Day 0 to Day 180
Assessment of overall treatment efficacy by the patient
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Measured: Day 30 to Day 180
Assessment of overall treatment efficacy by the investigator
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Measured: Day 30 to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 201122 Nov 2012

First posted29 Jun 2017
Study start21 Jun 2011
Primary completion22 Nov 2012
Study completion22 Nov 2012

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
Model description: This study was a multicentre, prospective, double-blind, randomised, controlled non-inferiority study in two parallel groups of patients followed up for six months.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03203408
Sponsor's protocol ID: OSTP-EUR-10-01
Other IDs: 2011-A00258-33
Status last verified: Oct 2017
First submitted: 22 Jun 2017
Last updated: 11 Oct 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis. A Randomised, Controlled, Double-blind, Parallel-group Study With a 6-month Follow-up
ClinicalTrials.gov ID: NCT03203408
Acronym / sponsor ID: OSTP-EUR-10-01
Conditions: Knee Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: TRB ChemedicaIndustry (pharma, biotech, devices)
Study start: 21 Jun 2011 (actual)
Primary completion: 22 Nov 2012 (actual)
Study completion: 22 Nov 2012 (actual)
First posted: 29 Jun 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: This study was a multicentre, prospective, double-blind, randomised, controlled non-inferiority study in two parallel groups of patients followed up for six months.

Arm	Type	Receives
OSTENIL PLUS	Experimental	Device: OSTENIL PLUSA single intra-articular injection of sodium hyaluronate 40 mg/2.0 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)
SYNVISC-ONE	Active comparator	Device: SYNVISC-ONEA single intra-articular injection of hylan G-F 20 48 mg/6 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female aged 40-85 years;
Primary knee osteoarthritis complying with the American College or Rheumatology criteria;
Radiographically defined osteoarthritis: joint space narrowing and osteophyte in X-ray taken less than one year previously and modified Kellgren-Lawrence grade Ib-III;
Symptoms on one side only, with a mean WOMAC A of ≥40 mm. If knee osteoarthritis is bilateral, a difference for that score between the contralateral knee and the selected knee should be of at least 20 mm;
Pain present on at least 15 days in the month before inclusion;

Key exclusion criteria (28 listed)

Knee osteoarthritis that is not symptomatic or insufficiently symptomatic;
Bilateral symptomatic knee osteoarthritis of the same severity on both sides;
Post-traumatic secondary knee osteoarthritis;
Knee osteoarthritis of radiographic grade I, Ia or IV;
Exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (Patellar syndrome);

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
OSTENIL PLUSInjection into the joint cavity of the most painful knee	Device	OSTENIL PLUS
SYNVISC-ONEInjection into the joint cavity of the most painful knee	Device	SYNVISC-ONE

Primary outcome

Change in WOMAC A
Time frame: Day 0 to Day 180
Change from baseline in the pain subscore (section A) of the WOMAC score

6 secondary outcomes

Lequesne algofunctional index
Time frame: Day 0 to Day 180
WOMAC B
Time frame: Day 0 to Day 180
WOMAC C
Time frame: Day 0 to Day 180
Patient's overall status score in relation to his/her knee osteoarthritis
Time frame: Day 0 to Day 180
Assessment of overall treatment efficacy by the patient
Time frame: Day 30 to Day 180
Assessment of overall treatment efficacy by the investigator
Time frame: Day 30 to Day 180

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 11 Oct 2017.
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.

Renée Liliane Dreiser, Dr study chair

APHP Bichat-Claude Bernard, Paris, France

Bernard Avouac, Dr study chair

APHP Henri Mondor, Creteil, France

Thomas Bardin, Prof. principal investigator

APHP Lariboisière, Paris, France

Questions about this trial

What is this clinical trial studying?

A study testing OSTENIL PLUS and SYNVISC-ONE in people with Knee Osteoarthritis, run by TRB Chemedica.

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 9 inclusion and 28 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 11 Oct 2017. 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?

Change in WOMAC A (time frame: Day 0 to Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03203408.

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 11 Oct 2017.