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
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
Treatments tested in this trial
- MISHA Knee System
- Non-Surgical Treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov