Performance of MOTO Medial® Unicompartmental Knee Arthroplasty

Launched by MEDACTA USA · Jul 5, 2017

Keywords

ClinConnect Summary

The clinical trial titled "Performance of MOTO Medial® Unicompartmental Knee Arthroplasty" is studying a specific type of knee surgery designed to help people with knee osteoarthritis, arthritis, or chronic knee pain. This surgery focuses on replacing only one part of the knee joint, rather than the entire joint, which can help improve mobility and reduce pain. The trial aims to gather information on how well this surgery works over time, based on patient feedback, clinical assessments, and imaging studies.

To participate in this trial, individuals must be at least 18 years old and able to understand and sign consent forms. They should have knee problems primarily affecting the inner part of the knee and should not have had previous knee surgeries on that specific area. It's important that participants can attend follow-up visits and complete surveys about their experiences. However, those with certain conditions, like knee ligament instability, inflammatory arthritis, or a history of knee infections, are not eligible. Overall, participants can expect to play a key role in helping researchers understand the effectiveness of this new knee procedure.

Gender

ALL

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).