Clinical trial NCT04574453: Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Sponsor class: NETWORK
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2020-10-05
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged between 40 and 80 years
2. 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);
3. Ambulant without assistance;
4. Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
5. VAS knee pain ≥40 at screening and 30 days before;
6. At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
7. Signed Informed consent

Exclusion Criteria:

1. Unstable knee;
2. Varus or valgus ≥ 15 degrees;
3. Active malignancy;
4. Knee trauma or lose body parts 1 year before screening;
5. Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
6. Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
7. Intra-articular HA or corticosteroid injection within 6 months before screening;
8. Arthroscopic or knee open surgery within 12 months before screening;
9. Body Mass Index (BMI) ≥ 40 kg/m2;
10. Active infection around the injection site;
11. Use of anticoagulants or history of thrombocytopenia;
12. Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
13. Known sensitivity to HA or DVS;
14. Pregnancy, breast feeding.

Primary outcomes:
measure: Change in Range Of Motion and Visual Analogue Scale
timeFrame: 180 days
Secondary outcomes:
measure: Physician Efficacy Global Evaluation
timeFrame: 180 days
measure: Visual Analogue Scale Evaluation
timeFrame: 180 days
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 180 days
measure: NSAID consumption
timeFrame: 180 days
Other outcomes:
measure: AE, SAE, ADE, SADE, DD incidence.
timeFrame: 180 days
measure: Physician Global Tolerability
timeFrame: 180 days
Locations:
city: Timişoara
country: Romania
facility: Fizio Center
state: Timis
Study officials:
affiliation: Fizio Center
name: George Puenea
role: PRINCIPAL_INVESTIGATOR
References: