Osteoarthritis, Knee
Conditions
Brief summary
Prospective, multicenter, two-arm, 2:1 randomized controlled trial (RCT) comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. This is the first randomized head-to-head study comparing outcomes from subjects treated with the MISHA Knee System.
Interventions
DEVICEMISHA Knee System
The MISHA Knee System is an extra-capsular knee implant intended to reduce loads on the medial knee. The implant consists of an absorber located between bases fixed with locking screws to the medial cortices of the distal femur and proximal tibia. The implant shares the load with the medial knee joint and articulating ball-and-sockets allow the device to accommodate the natural motions of the knee.
The non-surgical arm includes assist devices, physical conditioning, prescription or nonprescription medications, creams, vitamins, or supplements, intra-articular Injections, physical therapy and weight loss.
Sponsors
Moximed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization is programmed within the Electronic Data Capture system to ensure that the groups are unbiased and that the results are reliable, independent from the participant, investigator, and sponsor. The outcomes assessor remains independent from the participant, investigator and the sponsor.
Intervention model description
2:1 randomized controlled trial (RCT)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Activity exacerbated knee pain isolated to the medial compartment and not global in nature 2. WOMAC pain ≥ 40 3. Failed to find relief in non-surgical treatment modalities Key
Exclusion criteria
1. Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device 2. Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis) 3. Ligamentous instability 4. Active or recent knee infection 5. Inflammatory joint disease, including sequelae of viral infections 6. Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals 7. History of keloid, hypertrophic or contracture scaring 8. Propensity for restrictive scar formation or adhesions with prior procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Pain at 6 Months | 6 Months | Improvement in WOMAC Pain in the MISHA arm compared to the non-surgical arm measured on the initial cohort who complete the 6-month follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Function at 6 Months | 6 Months | Improvement in WOMAC Function in the MISHA arm to the non-surgical arm measured on the fully enrolled population who complete the 6-month follow-up visit |
Countries
United States
Contacts
CONTACTRose S Weinstein
STUDY_DIRECTORRose S Weinstein
Moximed
Outcome results
None listed