Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).

Conditions
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Knee Osteoarthritis, Knee Arthritis, Knee Pain Chronic

Intervention / Treatment
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* Device: MOTO Medial® UKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interventional : MOTO Medial® UKA<br>Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled. | Device: MOTO Medial® UKA<br>* Knee replacement surgery with the MOTO Medial® UKA<br>* Other names: Medial Unicondylar Knee Replacement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Knee Society Score Objective | Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire | 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 | 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. | post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months | 
| Knee Society Score | Assessment of pre-op expectations questionnaire | 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. | 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. | 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. | 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 | 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 | 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. | baseline, post-operative 2-6 weeks, 4-8 months | 
| Severity of osteoarthritis in the knee compartments | Determine by radiographic analysis for disease progression | Baseline | 
| Change from baseline in Knee Alignment | Determine by radiographic analysis Varus or Valgus | 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. | 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 | post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of knee Implant faliures | Reoperations, revisions, removals, and device related adverse events | 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 | Baseline | 
| Age of patient | Date of birth (age) | Baseline | 
| Demographics | Height in inches, weight in pounds to determine BMI | Baseline | 
| Number of male or female patients | Gender description male or female | Baseline | 
| Occurrence of Knee Treatments prior to surgery | Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures | Baseline | 
| Occurrence of prior medical and surgical history | Medical and surgical history of patient prior to knee surgery | Baseline | 
| Post-operative pain medications | Medications after knee surgery | 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 | post-operative 4-8 months, 9-15 months, 18-30 months | 
| Implant demographics | Implant femoral and tibial size and poly thickness | day of surgery | 
| Anesthetic | type of anesthesia used during surgery | day of surgery | 
| Estimated blood loss | Volume of blood loss during surgery | day of surgery | 
| Length of surgery | Time in minutes of skin to skin | day of surgery | 
| Length of Hospital Stay | Length of stay in hours | day of surgery | 
| Frequency of Facility type used for knee surgery | Type of facility used for knee surgery | day of surgery | 
| Tourniquet Time | Tourniquet time in minutes | day of surgery | 
| Complications | Assess adverse events and Serious adverse events | day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months |