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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Moebius Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01365260
First received: May 31, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Knee Osteoarthritis
 Device: MM-II
Device: DurolaneTM
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Moebius Medical Ltd.:

Primary Outcome Measures:
  • Number of participants with an acute inflammatory reaction in the injected knee [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 days and 7 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: Up to 90 days after the treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum global pain in the target knee [ Time Frame: Days -21, 0, 1, 3, 7, 14, 30, 90th ] [ Designated as safety issue: No ]
    Measured by Visual Analogue Scale for pain (VAS)

  • The Western Ontario and McMaster University OA index (WOMAC) [ Time Frame: Days 0, 7, 14, 30, 90 ] [ Designated as safety issue: No ]
  • The patient global assessment of treatment by Likert-scale questionnaire [ Time Frame: Days 0, 7, 14, 30, 90 ] [ Designated as safety issue: No ]
  • The patients acceptance of symptoms state (PASS) [ Time Frame: Days 7, 14, 30, 90 ] [ Designated as safety issue: No ]
  • Omeract-ORASI responders index [ Time Frame: Days 7, 14, 30 ] [ Designated as safety issue: No ]
  • The number of tablets of rescue medications used between visits [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365260

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

No publications provided

Responsible Party: Moebius Medical Ltd.
ClinicalTrials.gov Identifier: NCT01365260     History of Changes
Other Study ID Numbers: MM-002, 0196-11-HMO, HTA 5960
Study First Received: May 31, 2011
Last Updated: December 4, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013