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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
MISHA Knee System
DeviceThe 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 groups
120 Participants
are divided into 1 treatment groupGroup A: MISHA Knee SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from device- and procedure-related Subsequent Surgical Interventions
Time frame
5 years post-implantationSecondary outcomes
1
WOMAC Pain
Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of pain. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame
5 years2
WOMAC Function
Percent of subjects meeting clinically meaningful improvement (defined as ≥ 10-point change from baseline). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used for evaluation of function. The responses to each question are summed and the resultant scores are transformed to a 0-100 scale. A WOMAC score of zero (0) represents no knee problems and one hundred (100) represents extreme knee problems.
Time frame
5 years Source ClinicalTrials.gov