Clinical trial NCT03211663: Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
Official title: A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Knee Arthritis
Knee Pain Chronic
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2017-07-07
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery as part of routine care.

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.

Eligibility criteria: 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 outcomes:
measure: Change from baseline in Knee Society Score Objective
timeFrame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Knee Osteoarthritis Outcome Score
timeFrame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Forgotten Joint Score
timeFrame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Knee Society Score
timeFrame: Baseline
measure: Change from baseline in Knee Society Score
timeFrame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Veterans Rand 12 Score
timeFrame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Oxford Knee Score
timeFrame: Baseline, post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Medication for Osteoarthritis
timeFrame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline in Knee Wound Assessment
timeFrame: post-operative 2-6 weeks, 4-8 months
measure: Change from baseline in Visual Analog Scale score
timeFrame: baseline, post-operative 2-6 weeks, 4-8 months
measure: Severity of osteoarthritis in the knee compartments
timeFrame: Baseline
measure: Change from baseline in Knee Alignment
timeFrame: Baseline, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline of Implant position fixation
timeFrame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Change from baseline of implant survivorship
timeFrame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Secondary outcomes:
measure: Number of knee Implant faliures
timeFrame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: K & L Grading
timeFrame: Baseline
measure: Age of patient
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Number of male or female patients
timeFrame: Baseline
measure: Occurrence of Knee Treatments prior to surgery
timeFrame: Baseline
measure: Occurrence of prior medical and surgical history
timeFrame: Baseline
measure: Post-operative pain medications
timeFrame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
measure: Return to Work/Activity questionnaire
timeFrame: post-operative 4-8 months, 9-15 months, 18-30 months
measure: Implant demographics
timeFrame: day of surgery
measure: Anesthetic
timeFrame: day of surgery
measure: Estimated blood loss
timeFrame: day of surgery
measure: Length of surgery
timeFrame: day of surgery
measure: Length of Hospital Stay
timeFrame: day of surgery
measure: Frequency of Facility type used for knee surgery
timeFrame: day of surgery
measure: Tourniquet Time
timeFrame: day of surgery
measure: Complications
timeFrame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Other outcomes:
Locations:
city: Lady Lake
country: United States
facility: Unova Health Clinic
state: Florida
city: Louisville
country: United States
facility: Ellis & Badenhausen Orthopaedics PSC
state: Kentucky
city: Billings
country: United States
facility: Ortho Montana
state: Montana
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Meadville
country: United States
facility: Whole Health Joint Replacement
state: Pennsylvania
Study officials:
References: