Study of Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee

Study Overview
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Brief Summary
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A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee

Official Title
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A Pilot, Open, Randomised, Controlled, add-on Study Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee

Conditions
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Osteoarthritis Patient

Intervention / Treatment
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* Drug: Ostenil plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders between 40 and 70 years of age; Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria; Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline; Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale; Having given signed informed consent. Exclusion Criteria: Secondary knee osteoarthritis, including: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget's disease of bone; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis. Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline; Axial deviation > 15 degrees in valgus or varus on a standing X-ray; Clinically significant medio-lateral or antero-posterior instability; Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year; Significant injury to the signal knee within 6 months prior to baseline; Complete loss of range of motion; Painful knee conditions other than osteoarthritis (e.g., Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis); Necrosis of one of the femur condyles; History or evidence of gout, chondrocalcinosis; Peripheral neuropathy; Concomitant rheumatic disease: fibromyalgia; rheumatoid arthritis; collagen diseases; psoriatic arthritis and other seronegative spondylarthropathies (e.g., ankylosing spondylitis); metabolic and crystal-induced arthropathies; other osteopathies. Contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia); Skin disease in the area of injection; Severe coagulopathy, ongoing anticoagulation therapy; Accompanying OA of the hip of sufficient severity to interfere with the assessment of the signal knee; Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee; Poor general health interfering with compliance or assessment; Concomitant disease/ailment other than knee OA requiring the regular use of the patient's normal analgesic medicine; Initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline; Use of assistive devices other than a cane (walking stick); Surgery of the signal knee other than arthroscopy; Arthroscopy of the signal knee within one year prior to baseline; Treatment with symptomatic slow acting drug for OA (SYSADOA, i.e., chondroitin sulfate, diacerein, glucosamine, piascledine), unless the patient has been on a stable dose for at least 4 months prior to baseline; Intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline; Intra-articular SH injection into the signal knee within 6 months prior to baseline; Ascertained hypersensitivity to any product used in the study (SH, paracetamol, diclofenac, omeprazole) or to similar compounds; Pregnant or lactating female; Female of childbearing potential without adequate contraceptive methods; Participation in a drug clinical trial within 3 months prior screening; Patients who, in the judgement of the investigator, will not comply with the protocol.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ostenil plus<br>Patient will get Ostenil plus injection and standard treatment of Osteoarthritis | Drug: Ostenil plus<br>* 2% Sodium Hyaluronate plus Mannitol injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee. | WOMAC score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption. |  | 6 months |