Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

Medacta

Status: Active, not recruiting

Conditions: Knee Arthritis; Knee Pain Chronic; Knee Osteoarthritis

Treatments: Device: MOTO Medial® UKA

Study type: Observational

Funder types: Industry

Identifiers

NCT03211663

MUSA-K-MTM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 269 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

269 participants in 1 patient group

Interventional : MOTO Medial® UKA

Description:

Interventional : Patients who are planned to undergo a primary medial UKA using the MOTO Medial® will be enrolled.

Treatment:

Device: MOTO Medial® UKA