Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.

Detailed Description
-----------------
Osteoarthritis (OA) is the commonest form of joint disease, characterized by articular cartilage degradation with an accompanying periarticular bone response and a synovial membrane inflammation. Clinical manifestations of OA in the knee include pain in and around the joint, stiffness of the joint after rest, crepitus on motion and limited joint. MM-II medical device was designed to reduce wear and lower friction in knees of osteoarthritis patients by creating a lubricating layer onto cartilage surfaces upon injection. The purpose of this study is to determine whether a medical device MM-II is effective in the treatment of osteoarthritis, in direct comparison with an approved hyaluronic acid preparation.

Official Title
-----------------
A Double-Blind, Randomized, Feasibility Controlled Study to Assess the Safety and Efficacy of MM-II, an Injectable Intraarticular Medical Device, Intended to the Treatment of Symptomatic Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: MM-II
* Device: DurolaneTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic unilateral knee tibiofemoral OA Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray Knee pain within the last 24 hours before assessment more than 40mm on VAS Pain on most days in the last month Exclusion Criteria: Knee pain equal or more than 80mm on a 100mm VAS. Pain in the contra lateral knee; more than 30mm on a 100 VAS. Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis. Any condition that may interfere with the measure of pain in the targeted knee Concomitant meaningful synovial fluid effusion Post trauma OA Gross ligamentous instability of the knee

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MM-II<br> | Device: MM-II<br>* Single intraarticular (knee) injection of MM-II<br>|
| Active Comparator: DurolaneTM<br>hyaluronic acid | Device: DurolaneTM<br>* Single intraarticular (knee) injection of DurolaneTM<br>* Other names: hyaluronic acid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an acute inflammatory reaction in the injected knee | An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance | up to 7 days | 
| Change from baseline in blood count |  | 3 days and 7 days | 
| Number of participants with adverse events |  | Up to 90 days after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum global pain in the target knee | Measured by Visual Analogue Scale for pain (VAS) | Days -21, 0, 1, 3, 7, 14, 30, 90th | 
| The Western Ontario and McMaster University OA index (WOMAC) |  | Days 0, 7, 14, 30, 90 | 
| The patient global assessment of treatment by Likert-scale questionnaire |  | Days 0, 7, 14, 30, 90 | 
| The patients acceptance of symptoms state (PASS) |  | Days 7, 14, 30, 90 | 
| Omeract-ORASI responders index |  | Days 7, 14, 30 | 
| The number of tablets of rescue medications used between visits |  | During the study |