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

Moebius Medical Ltd.40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

MM-IIDEVICE

Single intraarticular (knee) injection of MM-II

DurolaneTMDEVICE

Single intraarticular (knee) injection of DurolaneTM

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Mount Scopus Hospital

Jerusalem, Israel

Outcomes

Primary Outcomes

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

Time frame: up to 7 days

Change from baseline in blood count

Time frame: 3 days and 7 days

Number of participants with adverse events

Time frame: Up to 90 days after the treatment

Secondary Outcomes

Maximum global pain in the target knee

Measured by Visual Analogue Scale for pain (VAS)

Time frame: Days -21, 0, 1, 3, 7, 14, 30, 90th

The Western Ontario and McMaster University OA index (WOMAC)

Time frame: Days 0, 7, 14, 30, 90

The patient global assessment of treatment by Likert-scale questionnaire

Time frame: Days 0, 7, 14, 30, 90

The patients acceptance of symptoms state (PASS)

Time frame: Days 7, 14, 30, 90

Omeract-ORASI responders index

Time frame: Days 7, 14, 30

The number of tablets of rescue medications used between visits

Time frame: During the study

Data from ClinicalTrials.gov

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