Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Iracross
* Device: Iraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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); 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iracross<br>1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml). | Device: Iracross<br>* Administration of max 2ml of Iracross at first visit<br>|
| Active Comparator: Iraline<br>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) | Device: Iraline<br>* Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Range Of Motion and Visual Analogue Scale | Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 180 days | 
| NSAID consumption | Incidence of NSAID consumption from first visit to final visit | 180 days |