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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

MM-II

DurolaneTM

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hadassah Mount Scopus Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MM-II

DurolaneTM

Arm Description

hyaluronic acid

Outcomes

Primary Outcome Measures

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

Change from baseline in blood count

Number of participants with adverse events

Secondary Outcome Measures

Maximum global pain in the target knee

Measured by Visual Analogue Scale for pain (VAS)

The Western Ontario and McMaster University OA index (WOMAC)

The patient global assessment of treatment by Likert-scale questionnaire

The patients acceptance of symptoms state (PASS)

Omeract-ORASI responders index

The number of tablets of rescue medications used between visits

Full Information

NCT ID

NCT01365260

First Posted

May 31, 2011

Last Updated

December 4, 2012

Sponsor

Moebius Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01365260

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Moebius Medical Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MM-II

Arm Type

Experimental

Arm Title

DurolaneTM

Arm Type

Active Comparator

Arm Description

hyaluronic acid

Intervention Type

Device

Intervention Name(s)

MM-II

Intervention Description

Single intraarticular (knee) injection of MM-II

Intervention Type

Device

Intervention Name(s)

DurolaneTM

Other Intervention Name(s)

hyaluronic acid

Intervention Description

Single intraarticular (knee) injection of DurolaneTM

Primary Outcome Measure Information:

Title

Number of participants with an acute inflammatory reaction in the injected knee

Description

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

Title

Change from baseline in blood count

Time Frame

3 days and 7 days

Title

Number of participants with adverse events

Time Frame

Up to 90 days after the treatment

Secondary Outcome Measure Information:

Title

Maximum global pain in the target knee

Description

Measured by Visual Analogue Scale for pain (VAS)

Time Frame

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

Title

The Western Ontario and McMaster University OA index (WOMAC)

Time Frame

Days 0, 7, 14, 30, 90

Title

The patient global assessment of treatment by Likert-scale questionnaire

Time Frame

Days 0, 7, 14, 30, 90

Title

The patients acceptance of symptoms state (PASS)

Time Frame

Days 7, 14, 30, 90

Title

Omeract-ORASI responders index

Time Frame

Days 7, 14, 30

Title

The number of tablets of rescue medications used between visits

Time Frame

During the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonid (Arieh) Kandel, MD

Organizational Affiliation

Hadassah Mount Scopus Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Mount Scopus Hospital

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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