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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: MM-II; Device: DurolaneTM

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Mount Scopus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MM-II	Device: MM-II; Single intraarticular (knee) injection of MM-II
Active Comparator: DurolaneTM; hyaluronic acid	Device: DurolaneTM; Single intraarticular (knee) injection of DurolaneTM; 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

Collaborators and Investigators

• Sponsor: Moebius Medical Ltd.
• Investigators: Principal Investigator: Leonid (Arieh) Kandel, MD, Hadassah Mount Scopus Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MM-002; 0196-11-HMO (Other Identifier: Hadassah Medical Center); HTA 5960 (Other Identifier: Israel Ministry of Health)