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

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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Iracross; Device: Iraline

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timişoara, Timis, Romania, 300211
      • Fizio Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE, SAE, ADE, SADE, DD incidence.	To investigate the overall safety and tolerability of the two medical devices during the by overall study period.	180 days
Physician Global Tolerability	Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation	180 days

Collaborators and Investigators

• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
• Collaborators: Opera CRO, a TIGERMED Group Company
• Investigators: Principal Investigator: George Puenea, Fizio Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2020
• Primary Completion (ACTUAL): February 10, 2021
• Study Completion (ACTUAL): February 10, 2021

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OPIRA/0519/MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No