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Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211663
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Medacta USA

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE July 7, 2017
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE October 9, 2017
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Change from baseline in Knee Society Score Objective [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]
    Assessment of pre-op expectations questionnaire
  • Change from baseline in Knee Society Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline ]
    Determine by radiographic analysis for disease progression
  • Change from baseline in Knee Alignment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • Number of knee Implant faliures [ Time Frame: 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
  • K & L Grading [ Time Frame: Baseline ]
    Assessment of Osteoarthritis Disease Grade of the knee compartment
  • Age of patient [ Time Frame: Baseline ]
    Date of birth (age)
  • Demographics [ Time Frame: Baseline ]
    Height in inches, weight in pounds to determine BMI
  • Number of male or female patients [ Time Frame: Baseline ]
    Gender description male or female
  • Occurrence of Knee Treatments prior to surgery [ Time Frame: Baseline ]
    Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
  • Occurrence of prior medical and surgical history [ Time Frame: Baseline ]
    Medical and surgical history of patient prior to knee surgery
  • Post-operative pain medications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: day of surgery ]
    Implant femoral and tibial size and poly thickness
  • Anesthetic [ Time Frame: day of surgery ]
    type of anesthesia used during surgery
  • Estimated blood loss [ Time Frame: day of surgery ]
    Volume of blood loss during surgery
  • Length of surgery [ Time Frame: day of surgery ]
    Time in minutes of skin to skin
  • Length of Hospital Stay [ Time Frame: day of surgery ]
    Length of stay in hours
  • Frequency of Facility type used for knee surgery [ Time Frame: day of surgery ]
    Type of facility used for knee surgery
  • Tourniquet Time [ Time Frame: day of surgery ]
    Tourniquet time in minutes
  • Complications [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
  • Implant survivorship [ Time Frame: 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
  • K & L Grading [ Time Frame: Baseline ]
    Assessment of Osteoarthritis Disease Grade of the knee compartment
  • Demographics [ Time Frame: Baseline ]
    Date of birth (age)
  • Demographics [ Time Frame: Baseline ]
    Height in inches, weight in pounds to determine BMI
  • Demographics [ Time Frame: Baseline ]
    Gender of male or female
  • Prior Knee Treatments [ Time Frame: Baseline ]
    Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures
  • Medical and surgical history [ Time Frame: Baseline ]
    Medical and surgical history of patient
  • Post-operative pain medications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: day of surgery ]
    Implant femoral and tibial size and poly thickness
  • Anesthetic [ Time Frame: day of surgery ]
    type of anesthesia used during surgery
  • Estimated blood loss [ Time Frame: day of surgery ]
    Volume of blood loss during surgery
  • Length of surgery [ Time Frame: day of surgery ]
    Time in minutes of skin to skin
  • Length of Stay [ Time Frame: day of surgery ]
    Length of stay in hours
  • Facility type [ Time Frame: day of surgery ]
    Facility used for surgery
  • Tourniquet Time [ Time Frame: day of surgery ]
    Tourniquet time in minutes
  • Complications [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Performance of MOTO Medial® Unicompartmental Knee Arthroplasty
Official Title  ICMJE A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Knee Arthritis
  • Knee Pain Chronic
Intervention  ICMJE Device: MOTO Medial® UKA
Knee replacement surgery with the MOTO Medial® UKA
Other Name: Medial Unicondylar Knee Replacement
Study Arms  ICMJE Interventional : MOTO Medial® UKA
Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.
Intervention: Device: MOTO Medial® UKA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
269
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date August 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mukesh Ahuja, MBBS, MS, CPI 312-548-9968 Mahuja@medacta.us.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03211663
Other Study ID Numbers  ICMJE MUSA-K-MTM-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medacta USA
Study Sponsor  ICMJE Medacta USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mukesh Ahuja, MBBS, MS, CPI Medacta USA
PRS Account Medacta USA
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP