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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Change in Range Of Motion and Visual Analogue Scale
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Iracross
1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml).
Intervention: Iracross (Device)
Iraline
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)
Intervention: Iraline (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Knee injury and Osteoarthritis Outcome Score(180 days)
- Visual Analogue Scale Evaluation(180 days)
- NSAID consumption(180 days)
- Physician Efficacy Global Evaluation(180 days)