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

Phase 1

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: MM-II; Device: DurolaneTM

• Registration Number: NCT01365260
• Lead Sponsor: Moebius Medical Ltd.

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.

Study Timeline

• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Study Start: 2011-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MM-II	MM-II	-
DurolaneTM	DurolaneTM	hyaluronic acid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1)

Hadassah Mount Scopus Hospital; 🇮🇱 Jerusalem, Israel