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

NCT ID: NCT01365260

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MM-II

Group Type EXPERIMENTAL

MM-II

Intervention Type DEVICE

Single intraarticular (knee) injection of MM-II

DurolaneTM

hyaluronic acid

Group Type ACTIVE_COMPARATOR

DurolaneTM

Intervention Type DEVICE

Single intraarticular (knee) injection of DurolaneTM

Interventions

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MM-II

Single intraarticular (knee) injection of MM-II

Intervention Type DEVICE

DurolaneTM

Single intraarticular (knee) injection of DurolaneTM

Intervention Type DEVICE

Other Intervention Names

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hyaluronic acid

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moebius Medical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leonid (Arieh) Kandel, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Mount Scopus Hospital

Locations

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Hadassah Mount Scopus Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0196-11-HMO

Identifier Type: OTHER

Identifier Source: secondary_id

HTA 5960

Identifier Type: OTHER

Identifier Source: secondary_id

MM-002

Identifier Type: -

Identifier Source: org_study_id