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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365260
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: MM-II Device: DurolaneTM Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: hyaluronic acid

Primary Outcome Measures :
  1. Number of participants with an acute inflammatory reaction in the injected knee [ Time Frame: up to 7 days ]
    An acute inflammatory reaction in more than 5% of the participants will be considered as manifestation of treatment related intolerance

  2. Change from baseline in blood count [ Time Frame: 3 days and 7 days ]
  3. Number of participants with adverse events [ Time Frame: Up to 90 days after the treatment ]

Secondary Outcome Measures :
  1. Maximum global pain in the target knee [ Time Frame: Days -21, 0, 1, 3, 7, 14, 30, 90th ]
    Measured by Visual Analogue Scale for pain (VAS)

  2. The Western Ontario and McMaster University OA index (WOMAC) [ Time Frame: Days 0, 7, 14, 30, 90 ]
  3. The patient global assessment of treatment by Likert-scale questionnaire [ Time Frame: Days 0, 7, 14, 30, 90 ]
  4. The patients acceptance of symptoms state (PASS) [ Time Frame: Days 7, 14, 30, 90 ]
  5. Omeract-ORASI responders index [ Time Frame: Days 7, 14, 30 ]
  6. The number of tablets of rescue medications used between visits [ Time Frame: During the study ]

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365260

Hadassah Mount Scopus Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Moebius Medical Ltd.
Principal Investigator: Leonid (Arieh) Kandel, MD Hadassah Mount Scopus Hospital

Responsible Party: Moebius Medical Ltd. Identifier: NCT01365260     History of Changes
Other Study ID Numbers: MM-002
0196-11-HMO ( Other Identifier: Hadassah Medical Center )
HTA 5960 ( Other Identifier: Israel Ministry of Health )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents