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

Sponsor
I.R.A. Istituto Ricerche Applicate S.p.A. (Other)
Overall Status
Completed
CT.gov ID
NCT04574453
Collaborator
Opera CRO, a TIGERMED Group Company (Other)
103
1
2
7.4
13.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Iracross
  • Device: Iraline
N/A

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
Actual Enrollment :
103 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 29, 2020
Actual Primary Completion Date :
Feb 10, 2021
Actual Study Completion Date :
Feb 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. 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

  4. NSAID consumption [180 days]

    Incidence of NSAID consumption from first visit to final visit

Other Outcome Measures

  1. AE, SAE, ADE, SADE, DD incidence. [180 days]

    To investigate the overall safety and tolerability of the two medical devices during the by overall study period.

  2. Physician Global Tolerability [180 days]

    Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fizio Center Timişoara Timis Romania 300211

Sponsors and Collaborators

  • I.R.A. Istituto Ricerche Applicate S.p.A.
  • Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: George Puenea, Fizio Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
I.R.A. Istituto Ricerche Applicate S.p.A.
ClinicalTrials.gov Identifier:
NCT04574453
Other Study ID Numbers:
  • OPIRA/0519/MD
First Posted:
Oct 5, 2020
Last Update Posted:
Apr 12, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2021