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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574453
• Other study ID #: OPIRA/0519/MD
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: April 2021
• Source: I.R.A. Istituto Ricerche Applicate S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Iracross
Administration of max 2ml of Iracross at first visit
• Iraline
Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need

Locations

Country	Name	City	State
Romania	Fizio Center	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
I.R.A. Istituto Ricerche Applicate S.p.A.	Opera Contract Research Organization a Tigermed company

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Physician Global Tolerability	Percentage of patients with "excellent" evaluations in the Physician Global Tolerability Evaluation	180 days
Primary	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	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
Secondary	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
Secondary	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
Secondary	NSAID consumption	Incidence of NSAID consumption from first visit to final visit	180 days