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

NCT ID: NCT04574453

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2021-02-10

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iracross

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

Group Type: EXPERIMENTAL

Iracross

Intervention Type: DEVICE

Administration of max 2ml of Iracross at first visit

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)

Group Type: ACTIVE_COMPARATOR

Iraline

Intervention Type: DEVICE

Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need

Interventions

Iracross

Administration of max 2ml of Iracross at first visit

Intervention Type: DEVICE

Iraline

Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

I.R.A. Istituto Ricerche Applicate S.p.A.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Puenea

Role: PRINCIPAL_INVESTIGATOR

Fizio Center

Locations

Fizio Center

Timișoara, Timiș County, Romania

Countries

Romania

Other Identifiers

OPIRA/0519/MD

Identifier Type: -

Identifier Source: org_study_id