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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Iracross; Device: Iraline

• Registration Number: NCT04574453
• Lead Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.

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 Timeline

• Study Start: 2020-06-29
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iracross	Iracross	1 course of IRACROSS (crosslinked 2% Hyaluronic Acid) at baseline, consisting of a mono-dose intra-articular administration (2ml).
Iraline	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)

Primary Outcome Measures

Name	Time	Method
Change in Range Of Motion and Visual Analogue Scale	180 days	Change in ROM and VAS for pain (at rest), at 180 (± 4 days) days

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score	180 days	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
Visual Analogue Scale Evaluation	180 days	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.
NSAID consumption	180 days	Incidence of NSAID consumption from first visit to final visit
Physician Efficacy Global Evaluation	180 days	Score of Physician Efficacy Global Evaluation at final visit. Minimum value is4-poor efficacy and maximum value is 1- very good efficacy

Trial Locations

Locations (1)

Fizio Center; 🇷🇴 Timişoara, Timis, Romania