Osteo Arthritis KneeNCT06118892
MISHA Post-Market Clinical Study
A study testing MISHA Knee System in people with Osteo Arthritis Knee, run by Moximed at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- MISHA Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Nov 2023to 30 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Failed non-operative OA treatment
Who cannot join
- 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
- Inflammatory joint disease, including sequalae of viral infections
- Suspected or documented allergy or hypersensitivity to cobalt, chromium, nickel or other metals
- History of keloid, hypertrophic or contracture scaring
- Propensity for restrictive scar formation or adhesions with prior procedures
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
David Diduch, MD
David Diduch, MD
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Dennis Crawford, MD
Dennis Crawford, MD
- Recruiting
Orthopaedics Specialists of NC
Raleigh, North Carolina, 27614
Mark Galland, MD
Mark Galland, MD
- Recruiting
Weiss Orthopedics
Sonoma, California, 95476
Noah Weiss
Noah Weiss, MD
About this study
Official title: Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
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.
Read more
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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- MISHA Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISHA Knee SystemDevice
Also called Implantable Shock Absorber (ISA)
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.
| Study group | Role | What they receive |
|---|---|---|
| MISHA Knee System | Experimental | Not described Receives: Device: MISHA Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device- and procedure-related Subsequent Surgical Interventions
Measured: 5 years post-implantation
Secondary outcomes (2)
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.
Measured: 5 years
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start3 Nov 2023
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moximed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Crawford, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118892
- Sponsor's protocol ID
- CP0009
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Evaluation of the MISHA® Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06118892
- Acronym / sponsor ID
- CP0009
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MoximedIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MISHA Knee System | Experimental | Device: MISHA Knee System |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Failed non-operative OA treatment
Key exclusion criteria (8 listed)
- 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
- Inflammatory joint disease, including sequalae of viral infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MISHA Knee SystemAlso: Implantable Shock Absorber (ISA)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. | Device | MISHA Knee System |
Primary outcome
Freedom from device- and procedure-related Subsequent Surgical Interventions
Time frame: 5 years post-implantation
2 secondary outcomes
WOMAC Pain
Time frame: 5 years
WOMAC Function
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Not yet recruiting
The PERK Study: Predicting and Evaluating Response to Knee RFA Using fNIRS
Osteo Arthritis of the Knee, Pain
Recruiting
Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
Osteo Arthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Crawford, MD principal investigator
Oregon Health and Science University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISHA Knee System in people with Osteo Arthritis Knee, run by Moximed at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rose Weinstein ((510) 887 3375, rsweinstein@moximed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device- and procedure-related Subsequent Surgical Interventions (time frame: 5 years post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.