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.
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 Type
OBSERVATIONAL
Enrollment
269
Knee replacement surgery with the MOTO Medial® UKA
Unova Health Clinic
Lady Lake, Florida, United States
Ellis & Badenhausen Orthopaedics PSC
Louisville, Kentucky, United States
Ortho Montana
Billings, Montana, United States
Duke University
Durham, North Carolina, United States
Change from baseline in Knee Society Score Objective
Assessment of improvement of clinical outcomes following knee replacement surgery using the Knee Society Score Questionnaire
Time frame: 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
Time frame: 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.
Time frame: post-operative 4-8 months, 9-15 months, 18-30 months and 51-69 months
Knee Society Score
Assessment of pre-op expectations questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Whole Health Joint Replacement
Meadville, Pennsylvania, United States
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: baseline, post-operative 2-6 weeks, 4-8 months
Severity of osteoarthritis in the knee compartments
Determine by radiographic analysis for disease progression
Time frame: Baseline
Change from baseline in Knee Alignment
Determine by radiographic analysis Varus or Valgus
Time frame: 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.
Time frame: 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
Time frame: post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months
Number of knee Implant faliures
Reoperations, revisions, removals, and device related adverse events
Time frame: 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
Time frame: Baseline
Age of patient
Date of birth (age)
Time frame: Baseline
Demographics
Height in inches, weight in pounds to determine BMI
Time frame: Baseline
Number of male or female patients
Gender description male or female
Time frame: Baseline
Occurrence of Knee Treatments prior to surgery
Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
Time frame: Baseline
Occurrence of prior medical and surgical history
Medical and surgical history of patient prior to knee surgery
Time frame: Baseline
Post-operative pain medications
Medications after knee surgery
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
Assessment of ability to return to work or other activities following surgery
Time frame: post-operative 4-8 months, 9-15 months, 18-30 months
Implant demographics
Implant femoral and tibial size and poly thickness
Time frame: day of surgery
Anesthetic
type of anesthesia used during surgery
Time frame: day of surgery
Estimated blood loss
Volume of blood loss during surgery
Time frame: day of surgery
Length of surgery
Time in minutes of skin to skin
Time frame: day of surgery
Length of Hospital Stay
Length of stay in hours
Time frame: day of surgery
Frequency of Facility type used for knee surgery
Type of facility used for knee surgery
Time frame: day of surgery
Tourniquet Time
Tourniquet time in minutes
Time frame: day of surgery
Complications
Assess adverse events and Serious adverse events
Time frame: day of surgery, post-operative 2-6 weeks, 4-8 months, 9-15 months, 18-30 months and 51-69 months