MOTION Clinical Trial

ConditionOsteoarthritis, Knee

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorMoximed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Activity exacerbated knee pain isolated to the medial compartment and not global in nature

WOMAC pain ≥ 40

Failed to find relief in non-surgical treatment modalities

Disqualifiers

Large medial osteophyte(s) or considerable extruded meniscus that may interfere with the placement or function of the device

Poor bone quality (e.g., bony erosion, osteopenia, osteoporosis)

Ligamentous instability

Active or recent knee infection

Trial design

Design model

Parallel

Treatments tested in this trial

MISHA Knee System
Device
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.
Non-Surgical Treatment
Other intervention
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 groups

100 Participants

are divided into 2 treatment groups

Group A: MISHA Knee SystemExperimental treatment 1 intervention

Group B: Non-Surgical TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

WOMAC Pain at 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

Time frame

6 Months

Secondary outcomes

WOMAC Function at 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

Time frame

6 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Moximed

Lead sponsor

Source ClinicalTrials.gov

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