Safety and Efficacy of an Injectable Medical Device to Treat Knee Osteoarthritis
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
3 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 knee-osteoarthritis
Started Oct 2011
Shorter than P25 for phase_1 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedDecember 5, 2012
December 1, 2012
1.1 years
May 31, 2011
December 4, 2012
Conditions
Outcome Measures
Primary Outcomes (3)
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
up to 7 days
Change from baseline in blood count
3 days and 7 days
Number of participants with adverse events
Up to 90 days after the treatment
Secondary Outcomes (6)
Maximum global pain in the target knee
Days -21, 0, 1, 3, 7, 14, 30, 90th
The Western Ontario and McMaster University OA index (WOMAC)
Days 0, 7, 14, 30, 90
The patient global assessment of treatment by Likert-scale questionnaire
Days 0, 7, 14, 30, 90
The patients acceptance of symptoms state (PASS)
Days 7, 14, 30, 90
Omeract-ORASI responders index
Days 7, 14, 30
- +1 more secondary outcomes
Study Arms (2)
MM-II
EXPERIMENTALDurolaneTM
ACTIVE COMPARATORhyaluronic acid
Interventions
Single intraarticular (knee) injection of DurolaneTM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Mount Scopus Hospital
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leonid (Arieh) Kandel, MD
Hadassah Mount Scopus Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 3, 2011
Study Start
October 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
December 5, 2012
Record last verified: 2012-12