MISHA Post-Market Clinical Study
ConditionOsteo Arthritis Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorMoximed
About this trial
Prospective evaluation of the safety and effectiveness of the MISHA Knee System.
The study will collect data on the procedural and long-term adverse events, WOMAC pain and function scores, KSS satisfaction, subsequent surgical interventions, BMI levels, range of motion, UCLA activity level of the subjects, and perform radiographic/x-ray evaluations at clinical visits through 5 years post-procedure.
The primary analysis of this study is freedom from device- and procedure-related SSIs at five (5) years post-implantation.
This study will also assess device performance in subjects with intact and retained devices and subjects with devices removed prior to study termination and freedom from conversion to arthroplasty through 5 years.
Study subjects will be followed over a five-year post-implant period.
Eligibility criteria
Qualifiers
Subjects aged 25 to 65 years at time of index procedure
Body Mass Index (BMI) of < 35
Activity exacerbated knee pain isolated to the medial compartment and not global in nature
WOMAC pain ≥ 40
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
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov