MOTION Clinical Trial

Moximed

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Other: Non-Surgical Treatment; Device: MISHA Knee System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06843980

CP0011

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

MISHA Knee System

Experimental group

Description:

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.

Treatment:

Device: MISHA Knee System

Non-Surgical Treatment

Active Comparator group

Description:

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.

Treatment:

Other: Non-Surgical Treatment