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

Moebius Medical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Knee Osteoarthritis

Treatments

Device: DurolaneTM

Device: MM-II

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365260

HTA 5960 (Other Identifier)

0196-11-HMO (Other Identifier)

MM-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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