Knee OsteoarthritisNCT03211663
Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
An observational study of Knee Osteoarthritis and Knee Arthritis, run by Medacta USA at 5 sites in United States.
Trial summary
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
- What is being tested?
- MOTO Medial® UKA
- Type of treatment
- Medical device
- How many people
- 269 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Oct 2017to 1 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing surgery as part of routine care.
Who may be able to join
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Ability to understand and provide written authorization for use and disclosure of personal health information.
- Subject who are able and willing to comply with the study protocol and follow-up visits.
- Must be 18 years or older to participate.
- Subjects must have medial knee disease in the affected knee compliant with the FDA-approved indications for use of MOTO Medial® UKA.
- Must have had no prior arthroplasty to the medial compartment of the study knee.
- Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete Patient Reported Outcome questionnaires, physical exam and radiographs.
Who cannot join
- Knee ligament instability (deficiency of cruciate or collateral ligaments)
- Inflammatory Arthritis
- History of prior knee infection
- History of Alcoholism or Drug Abuse
- Currently on chemotherapy or radiation therapy for neoplastic disease. Medacta MOTO Medial® Version 1 Confidential Page 9 of 36 June 5, 2017
- Currently on immunosuppressive medications including steroids
Show all 15Show fewer
- History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
- Habitual use of narcotic pain medications prior to surgery (more than 3 doses or pills per week)
- History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
- History of chronic pain issues for reasons other than knee pain.
- Women who are pregnant.
- Psychiatric illness
- Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
- Prior joint arthroplasty on the target knee, including prior medial UKA (revision), lateral UKA, or Patellofemoral Joint
- Prior high tibial osteotomy (HTO).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ortho Montana
Billings, Montana, 59102
Duke University
Durham, North Carolina, 27710
Unova Health Clinic
Lady Lake, Florida, 32159
Ellis & Badenhausen Orthopaedics PSC
Louisville, Kentucky, 40223
Whole Health Joint Replacement
Meadville, Pennsylvania, 16335
About this study
Official title: A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.
Read the detailed description
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings and radiographic analysis. Additionally, several perioperative factors, medical and surgical history will be evaluated. Implant survival and complications will be detailed throughout the study. Data from pre-operative evaluation, day of surgery, and post-operatively at 4 weeks, 6 months, and years 1, 2 \& 5, will be collected.
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
- Being tested
- MOTO Medial® UKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTO Medial® UKADevice
Also called Medial Unicondylar Knee Replacement
Knee replacement surgery with the MOTO Medial® UKA
| Study group | Role | What they receive |
|---|---|---|
| Interventional : MOTO Medial® UKA | Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled. Receives: Device: MOTO Medial® UKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Knee Society Score Objective
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Measured: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Knee Osteoarthritis Outcome Score
Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire
Measured: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Forgotten Joint Score
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
Measured: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Knee Society Score
Assessment of pre-op expectations questionnaire
Measured: Baseline
Change from baseline in Knee Society Score
Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
Measured: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Veterans Rand 12 Score
Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
Measured: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Oxford Knee Score
Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
Measured: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Medication for Osteoarthritis
Documentation of osteoarthritis medications
Measured: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline in Knee Wound Assessment
Assessment of wound drainage, swelling and infection in surgical knee
Measured: post-operative 2-6 weeks, 4-8 months
Change from baseline in Visual Analog Scale score
Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
Measured: baseline, post-operative 2-6 weeks, 4-8 months
Severity of osteoarthritis in the knee compartments
Determine by radiographic analysis for disease progression
Measured: Baseline
Change from baseline in Knee Alignment
Determine by radiographic analysis Varus or Valgus
Measured: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline of Implant position fixation
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
Measured: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Change from baseline of implant survivorship
Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear
Measured: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Secondary outcomes (17)
Number of knee Implant faliures
Reoperations, revisions, removals, and device related adverse events
Measured: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
K & L Grading
Assessment of Osteoarthritis Disease Grade of the knee compartment
Measured: Baseline
Age of patient
Date of birth (age)
Measured: Baseline
Demographics
Height in inches, weight in pounds to determine BMI
Measured: Baseline
Number of male or female patients
Gender description male or female
Measured: Baseline
Occurrence of Knee Treatments prior to surgery
Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
Measured: Baseline
Occurrence of prior medical and surgical history
Medical and surgical history of patient prior to knee surgery
Measured: Baseline
Post-operative pain medications
Medications after knee surgery
Measured: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Return to Work/Activity questionnaire
Assessment of ability to return to work or other activities following surgery
Measured: post-operative 4-8 months, 9-15 months, 18-30 months
Implant demographics
Implant femoral and tibial size and poly thickness
Measured: day of surgery
Anesthetic
type of anesthesia used during surgery
Measured: day of surgery
Estimated blood loss
Volume of blood loss during surgery
Measured: day of surgery
Length of surgery
Time in minutes of skin to skin
Measured: day of surgery
Length of Hospital Stay
Length of stay in hours
Measured: day of surgery
Frequency of Facility type used for knee surgery
Type of facility used for knee surgery
Measured: day of surgery
Tourniquet Time
Tourniquet time in minutes
Measured: day of surgery
Complications
Assess adverse events and Serious adverse events
Measured: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start9 Oct 2017
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medacta USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211663
- Sponsor's protocol ID
- MUSA-K-MTM-001
- Status last verified
- Sep 2025
- First submitted
- 28 Jun 2017
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
- ClinicalTrials.gov ID
- NCT03211663
- Acronym / sponsor ID
- MUSA-K-MTM-001
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Medacta USAIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Jul 2017 (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.
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® Unicompartmental Knee Arthroplasty (UKA), with patient report outcomes, clinical findings and radiographic analysis.
Detailed description
This is a prospective, multi-center study, designed to assess mid-term performance of the MOTO Medial® UKA, with patient report outcomes, clinical findings and radiographic analysis. Additionally, several perioperative factors, medical and surgical history will be evaluated. Implant survival and complications will be detailed throughout the study. Data from pre-operative evaluation, day of surgery, and post-operatively at 4 weeks, 6 months, and years 1, 2 \& 5, will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional : MOTO Medial® UKA | – | Device: MOTO Medial® UKAInterventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery as part of routine care.
Key inclusion criteria (7 listed)
- Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).
Key exclusion criteria (15 listed)
- Knee ligament instability (deficiency of cruciate or collateral ligaments)
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 |
|---|---|---|
| MOTO Medial® UKAAlso: Medial Unicondylar Knee ReplacementKnee replacement surgery with the MOTO Medial® UKA | Device | Interventional : MOTO Medial® UKA |
Primary outcome
Change from baseline in Knee Society Score Objective
Time frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Change from baseline in Knee Osteoarthritis Outcome Score
Time frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of improvement of activity levels following knee replacement surgery using the Knee Osteoarthritis Score Questionnaire
Change from baseline in Forgotten Joint Score
Time frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Forgotten Joint Score Questionnaire.
Knee Society Score
Time frame: Baseline
Assessment of pre-op expectations questionnaire
Change from baseline in Knee Society Score
Time frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement post-op satisfaction following knee replacement surgery using the Knee Society Score questionnaire.
Change from baseline in Veterans Rand 12 Score
Time frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of your health using the Veterans Rand 12 score questionnaire.
Change from baseline in Oxford Knee Score
Time frame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Assessment of the improvement of knee function following knee replacement surgery using the Oxford Knee Score questionnaire.
Change from baseline in Medication for Osteoarthritis
Time frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Documentation of osteoarthritis medications
Change from baseline in Knee Wound Assessment
Time frame: post-operative 2-6 weeks, 4-8 months
Assessment of wound drainage, swelling and infection in surgical knee
Change from baseline in Visual Analog Scale score
Time frame: baseline, post-operative 2-6 weeks, 4-8 months
Assessment of the improvement of patient knee pain following knee replacement surgery using the VAS score questionnaire.
Severity of osteoarthritis in the knee compartments
Time frame: Baseline
Determine by radiographic analysis for disease progression
Change from baseline in Knee Alignment
Time frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis Varus or Valgus
Change from baseline of Implant position fixation
Time frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis by measuring Radio Lucent lines in millimeters.
Change from baseline of implant survivorship
Time frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Determine by radiographic analysis of bone fracture, implant fracture, fixation and wear
17 secondary outcomes
Number of knee Implant faliures
Time frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
K & L Grading
Time frame: Baseline
Age of patient
Time frame: Baseline
Demographics
Time frame: Baseline
Number of male or female patients
Time frame: Baseline
Occurrence of Knee Treatments prior to surgery
Time frame: Baseline
Occurrence of prior medical and surgical history
Time frame: Baseline
Post-operative pain medications
Time frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Return to Work/Activity questionnaire
Time frame: post-operative 4-8 months, 9-15 months, 18-30 months
Implant demographics
Time frame: day of surgery
Anesthetic
Time frame: day of surgery
Estimated blood loss
Time frame: day of surgery
Length of surgery
Time frame: day of surgery
Length of Hospital Stay
Time frame: day of surgery
Frequency of Facility type used for knee surgery
Time frame: day of surgery
Tourniquet Time
Time frame: day of surgery
Complications
Time frame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Knee Arthritis, run by Medacta USA at 5 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 7 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Knee Society Score Objective (time frame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months). The study lists 14 primary outcomes in all. 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 25 Sep 2025.