Knee Osteoarthritis
Conditions
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.
Interventions
DEVICEMM-II
Single intraarticular (knee) injection of MM-II
DEVICEDurolaneTM
Single intraarticular (knee) injection of DurolaneTM
Sponsors
Moebius Medical Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with an acute inflammatory reaction in the injected knee | up to 7 days | An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance |
| 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
| Measure | Time frame | Description |
|---|---|---|
| The patients acceptance of symptoms state (PASS) | Days 7, 14, 30, 90 | — |
| Maximum global pain in the target knee | Days -21, 0, 1, 3, 7, 14, 30, 90th | Measured by Visual Analogue Scale for pain (VAS) |
| The number of tablets of rescue medications used between visits | During the study | — |
| Omeract-ORASI responders index | Days 7, 14, 30 | — |
| 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 | — |
Countries
Israel
Outcome results
None listed