Clinical Trials in the USA / NCT03211663
Active, not recruiting
Observational
Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
NCT03211663 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Knee OsteoarthritisKnee ArthritisKnee Pain Chronic
Investigational drug(s) / intervention(s)
MOTO Medial® UKA
MOTO Medial® UKA: Knee replacement surgery with the MOTO Medial® UKA
Study 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.
Eligibility
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).
Primary outcome measure(s)
- 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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Unova Health Clinic | Lady Lake | Florida | |
| Ellis & Badenhausen Orthopaedics PSC | Louisville | Kentucky | |
| Ortho Montana | Billings | Montana | |
| Duke University | Durham | North Carolina | |
| Whole Health Joint Replacement | Meadville | Pennsylvania |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03211663 on ClinicalTrials.gov ↗ ← All trials in the USA