Knee Arthritis, Knee Osteoarthritis, Knee Pain Chronic
Conditions
Brief 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.
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.
Interventions
DEVICEMOTO Medial® UKA
Knee replacement surgery with the MOTO Medial® UKA
Sponsors
Medacta USA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Knee Society Score Objective | 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 | 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 | 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 | Baseline | Assessment of pre-op expectations questionnaire |
| Change from baseline in Knee Society Score | 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 | 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 | 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 | 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 | 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 | 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 | Baseline | Determine by radiographic analysis for disease progression |
| Change from baseline in Knee Alignment | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Facility type used for knee surgery | day of surgery | Type of facility used for knee surgery |
| Number of knee Implant faliures | post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months | Reoperations, revisions, removals, and device related adverse events |
| Complications | day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months | Assess adverse events and Serious adverse events |
| Tourniquet Time | day of surgery | Tourniquet time in minutes |
| K & L Grading | Baseline | Assessment of Osteoarthritis Disease Grade of the knee compartment |
| Age of patient | Baseline | Date of birth (age) |
| Demographics | Baseline | Height in inches, weight in pounds to determine BMI |
| Number of male or female patients | Baseline | Gender description male or female |
| Occurrence of Knee Treatments prior to surgery | Baseline | Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures |
| Occurrence of prior medical and surgical history | Baseline | Medical and surgical history of patient prior to knee surgery |
| Post-operative pain medications | post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months | Medications after knee surgery |
| Return to Work/Activity questionnaire | post-operative 4-8 months, 9-15 months, 18-30 months | Assessment of ability to return to work or other activities following surgery |
| Implant demographics | day of surgery | Implant femoral and tibial size and poly thickness |
| Anesthetic | day of surgery | type of anesthesia used during surgery |
| Estimated blood loss | day of surgery | Volume of blood loss during surgery |
| Length of surgery | day of surgery | Time in minutes of skin to skin |
| Length of Hospital Stay | day of surgery | Length of stay in hours |
Countries
United States
Outcome results
None listed