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

NCT04574453 | Completed DMC

• 1 other identifier: OPIRA/0519/MD
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Physician Efficacy Global Evaluation

  180 days

• Visual Analogue Scale Evaluation

  180 days

• Knee injury and Osteoarthritis Outcome Score

  180 days

• NSAID consumption

  180 days

Other Outcomes (2)

• AE, SAE, ADE, SADE, DD incidence.

  180 days

• Physician Global Tolerability

  180 days

Study Arms (2)

Iracross

EXPERIMENTAL

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

Device: Iracross

Iraline

ACTIVE COMPARATOR

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

Interventions

Iracross DEVICE

Administration of max 2ml of Iracross at first visit

Iracross

Iraline DEVICE

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

Iraline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40 and 80 years
• 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);
• Ambulant without assistance;
• Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
• VAS knee pain ≥40 at screening and 30 days before;
• At least 30 days before screening oral/parenteral corticosteroid or NSAIDs (10 mg prednisone) administration.
• Signed Informed consent

You may not qualify if:

• Unstable knee;
• Varus or valgus ≥ 15 degrees;
• Active malignancy;
• Knee trauma or lose body parts 1 year before screening;
• Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
• Use of potent analgesics 15 days (different from ≤ 10 mg prednisone);
• Intra-articular HA or corticosteroid injection within 6 months before screening;
• Arthroscopic or knee open surgery within 12 months before screening;
• Body Mass Index (BMI) ≥ 40 kg/m2;
• Active infection around the injection site;
• Use of anticoagulants or history of thrombocytopenia;
• Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
• Known sensitivity to HA or DVS;
• Pregnancy, breast feeding.

Sponsors & Collaborators

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

Study Sites (1)

Fizio Center

Timișoara, Timiș County, 300211, Romania

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• George Puenea

  Fizio Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: June 29, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

RO (1)