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
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
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
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
No
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
No
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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