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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 : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Medacta USA

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Knee Arthritis Knee Pain Chronic Device: MOTO Medial® UKA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 269 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Interventional : MOTO Medial® UKA
Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.
Device: MOTO Medial® UKA
Knee replacement surgery with the MOTO Medial® UKA
Other Name: Medial Unicondylar Knee Replacement




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. Knee Society Score [ Time Frame: Baseline ]
    Assessment of pre-op expectations questionnaire

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. Severity of osteoarthritis in the knee compartments [ Time Frame: Baseline ]
    Determine by radiographic analysis for disease progression

  12. 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

  13. 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.

  14. 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


Secondary Outcome Measures :
  1. 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

  2. K & L Grading [ Time Frame: Baseline ]
    Assessment of Osteoarthritis Disease Grade of the knee compartment

  3. Age of patient [ Time Frame: Baseline ]
    Date of birth (age)

  4. Demographics [ Time Frame: Baseline ]
    Height in inches, weight in pounds to determine BMI

  5. Number of male or female patients [ Time Frame: Baseline ]
    Gender description male or female

  6. Occurrence of Knee Treatments prior to surgery [ Time Frame: Baseline ]
    Prior treatments of knee such as bracing, medication, injections, arthroscopy, ligament and cartilage procedures

  7. Occurrence of prior medical and surgical history [ Time Frame: Baseline ]
    Medical and surgical history of patient prior to knee surgery

  8. 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

  9. 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

  10. Implant demographics [ Time Frame: day of surgery ]
    Implant femoral and tibial size and poly thickness

  11. Anesthetic [ Time Frame: day of surgery ]
    type of anesthesia used during surgery

  12. Estimated blood loss [ Time Frame: day of surgery ]
    Volume of blood loss during surgery

  13. Length of surgery [ Time Frame: day of surgery ]
    Time in minutes of skin to skin

  14. Length of Hospital Stay [ Time Frame: day of surgery ]
    Length of stay in hours

  15. Frequency of Facility type used for knee surgery [ Time Frame: day of surgery ]
    Type of facility used for knee surgery

  16. Tourniquet Time [ Time Frame: day of surgery ]
    Tourniquet time in minutes

  17. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211663


Contacts
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Contact: Mukesh Ahuja, MBBS, MS, CPI 312-548-9968 Mahuja@medacta.us.com

Locations
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United States, Florida
Unova Health Clinic Recruiting
Lady Lake, Florida, United States, 32159
Contact: J Mandume Kerina, MD         
United States, Kentucky
Ellis & Badenhausen Orthopaedics PSC Recruiting
Louisville, Kentucky, United States, 40223
Contact: Akbar Nawab, MD         
Sponsors and Collaborators
Medacta USA
Investigators
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Study Director: Mukesh Ahuja, MBBS, MS, CPI Medacta USA
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Responsible Party: Medacta USA
ClinicalTrials.gov Identifier: NCT03211663    
Other Study ID Numbers: MUSA-K-MTM-001
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases