Performance of MOTO Medial® Unicompartmental Knee Arthroplasty



Status:Recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:October 9, 2017
End Date:December 1, 2025
Contact:Mukesh Ahuja, MBBS, MS, CPI
Email:Mahuja@medacta.us.com
Phone:312-548-9968

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A Prospective, Multi-Center Study To Assess Performance of MOTO Medial® in Unicompartmental Knee Arthroplasty (UKA).

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.

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).
We found this trial at
2
sites
13151 Magisterial Drive
Louisville, Kentucky 40223
?
mi
from
Louisville, KY
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539 Rolling Acres Road
Lady Lake, Florida 32159
?
mi
from
Lady Lake, FL
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