Osteoarthritis, KneeNCT04574453
Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
A study testing Iracross and Iraline in people with Osteoarthritis, Knee, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
Trial summary
Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Iracross and Iraline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteRomania
- Study dates
- 29 Jun 2020to 10 Feb 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 80 years
- Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III);
- Ambulant without assistance;
- Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
- VAS knee pain ≥40 at screening and 30 days before;
- At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
- Signed Informed consent
Who cannot join
- Unstable knee;
- Varus or valgus ≥ 15 degrees;
- Active malignancy;
- Knee trauma or lose body parts 1 year before screening;
- Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
- Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
Show all 14Show fewer
- Intra-articular HA or corticosteroid injection within 6 months before screening;
- Arthroscopic or knee open surgery within 12 months before screening;
- Body Mass Index (BMI) ≥ 40 kg/m2;
- Active infection around the injection site;
- Use of anticoagulants or history of thrombocytopenia;
- Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
- Known sensitivity to HA or DVS;
- Pregnancy, breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Paralel Goup Study To Assess With A Non- Inferiority Hypothesis The Efficacy And Safety Of The Medical Device Iracross (Crosslinked 2% Hyaluronic Acid) Versus The Medical Device Iraline (Linear 2% Hyaluronic Acid), Administered Intra-Articular To Patients With Knee Osteoarthritis
Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical activity history to athletes).
Read the detailed description
After giving their consent, subjects will undergo a screening visit to determine eligibility for study entry. After randomization, subjects will have administered medical device Iracross or Iraline. For subjects allocated to Iracross, medical device will be administered only at first visit and for subjects allocated to Iraline, medical device will be administered at visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Iracross, Iraline
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IracrossDevice
Administration of max 2ml of Iracross at first visit
IralineDevice
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
| Study group | Role | What they receive |
|---|---|---|
| Iracross | Experimental | 1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml). Receives: Device: Iracross |
| Iraline | Active comparator | 1 course of IRALINE (linear 2% Hyaluronic Acid); each course consists of 3-5 intra-articular administrations (2ml) at weekly intervals (from week 1 to 3, 4 or 5, depending on each patient's need) Receives: Device: Iraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Range Of Motion and Visual Analogue Scale
Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days
Measured: 180 days
Secondary outcomes (4)
Physician Efficacy Global Evaluation
Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy
Measured: 180 days
Visual Analogue Scale Evaluation
VAS for pain (on moving and on pressing). Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.
Measured: 180 days
Knee injury and Osteoarthritis Outcome Score
Changes in KOOS score from first visit to final visit. The min value is 0 and the max value 100, were the min value represents no problem and max value represents extreme problems
Measured: 180 days
NSAID consumption
Incidence of NSAID consumption from first visit to final visit
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start29 Jun 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
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.
- 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
- Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Sponsor type
- Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- George Puenea, Principal investigator, Fizio Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574453
- Sponsor's protocol ID
- OPIRA/0519/MD
- Status last verified
- Apr 2021
- First submitted
- 28 Sep 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Paralel Goup Study To Assess With A Non- Inferiority Hypothesis The Efficacy And Safety Of The Medical Device Iracross (Crosslinked 2% Hyaluronic Acid) Versus The Medical Device Iraline (Linear 2% Hyaluronic Acid), Administered Intra-Articular To Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04574453
- Acronym / sponsor ID
- OPIRA/0519/MD
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 5 Oct 2020 (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.
Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to objectively evaluate the composite measurement of ROM, pain and basic activities like walking or performing daily activities (QoL) in a population with a large coverage of age and levels of physical activity (from no physical activity history to athletes).
Detailed description
After giving their consent, subjects will undergo a screening visit to determine eligibility for study entry. After randomization, subjects will have administered medical device Iracross or Iraline. For subjects allocated to Iracross, medical device will be administered only at first visit and for subjects allocated to Iraline, medical device will be administered at visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
| Arm | Type | Receives |
|---|---|---|
| Iracross | Experimental | Device: Iracross1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml). |
| Iraline | Active comparator | Device: Iraline1 course of IRALINE (linear 2% Hyaluronic Acid); each course consists of 3-5 intra-articular administrations (2ml) at weekly intervals (from week 1 to 3, 4 or 5, depending on each patient's need) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged between 40 and 80 years
- Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria; (for subjects with OA at both knees, the most painful one will be included in the study only, respecting KL grade II or III);
- Ambulant without assistance;
- Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
- VAS knee pain ≥40 at screening and 30 days before;
Key exclusion criteria (14 listed)
- Unstable knee;
- Varus or valgus ≥ 15 degrees;
- Active malignancy;
- Knee trauma or lose body parts 1 year before screening;
- Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
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 |
|---|---|---|
| IracrossAdministration of max 2ml of Iracross at first visit | Device | Iracross |
| IralineAdministration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need | Device | Iraline |
Primary outcome
Change in Range Of Motion and Visual Analogue Scale
Time frame: 180 days
Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days
4 secondary outcomes
Physician Efficacy Global Evaluation
Time frame: 180 days
Visual Analogue Scale Evaluation
Time frame: 180 days
Knee injury and Osteoarthritis Outcome Score
Time frame: 180 days
NSAID consumption
Time frame: 180 days
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 12 Apr 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.
George Puenea principal investigator
Fizio Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iracross and Iraline in people with Osteoarthritis, Knee, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 1 site in Romania.
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 7 inclusion and 14 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 12 Apr 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 Romania. 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 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 Range Of Motion and Visual Analogue Scale (time frame: 180 days). 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 Apr 2021.