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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Viscosupplements

ClinicalTrials.gov processed this record on October 22, 2014