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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365260
• Other study ID #: MM-002
• Secondary ID: 0196-11-HMOHTA 5
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 31, 2011
• Last updated: December 4, 2012
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Moebius Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• MM-II
Single intraarticular (knee) injection of MM-II
• DurolaneTM
Single intraarticular (knee) injection of DurolaneTM

Locations

Country	Name	City	State
Israel	Hadassah Mount Scopus Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Moebius Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Change from baseline in blood count		3 days and 7 days	Yes
Primary	Number of participants with adverse events		Up to 90 days after the treatment	Yes
Secondary	Maximum global pain in the target knee	Measured by Visual Analogue Scale for pain (VAS)	Days -21, 0, 1, 3, 7, 14, 30, 90th	No
Secondary	The Western Ontario and McMaster University OA index (WOMAC)		Days 0, 7, 14, 30, 90	No
Secondary	The patient global assessment of treatment by Likert-scale questionnaire		Days 0, 7, 14, 30, 90	No
Secondary	The patients acceptance of symptoms state (PASS)		Days 7, 14, 30, 90	No
Secondary	Omeract-ORASI responders index		Days 7, 14, 30	No
Secondary	The number of tablets of rescue medications used between visits		During the study	No