Clinical trial NCT01365260: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Lead sponsor: Moebius Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with an acute inflammatory reaction in the injected knee
timeFrame: up to 7 days
measure: Change from baseline in blood count
timeFrame: 3 days and 7 days
measure: Number of participants with adverse events
timeFrame: Up to 90 days after the treatment
Secondary outcomes:
measure: Maximum global pain in the target knee
timeFrame: Days -21, 0, 1, 3, 7, 14, 30, 90th
measure: The Western Ontario and McMaster University OA index (WOMAC)
timeFrame: Days 0, 7, 14, 30, 90
measure: The patient global assessment of treatment by Likert-scale questionnaire
timeFrame: Days 0, 7, 14, 30, 90
measure: The patients acceptance of symptoms state (PASS)
timeFrame: Days 7, 14, 30, 90
measure: Omeract-ORASI responders index
timeFrame: Days 7, 14, 30
measure: The number of tablets of rescue medications used between visits
timeFrame: During the study
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Mount Scopus Hospital
Study officials:
affiliation: Hadassah Mount Scopus Hospital
name: Leonid (Arieh) Kandel, MD
role: PRINCIPAL_INVESTIGATOR
References: