Clinical Outcomes With Omni Apex Ultracongruent Knee System
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ClinicalTrials.gov Identifier: NCT01367938
Recruitment Status :
Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : December 13, 2017
Spokane Joint Replacement Center
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
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Ages Eligible for Study:
21 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients undergoing total knee replacement
Patients willing to sign the informed consent.
Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self-evaluations.
Male and non-pregnant female patients ages 21-80 years of age at time of surgery.
Patients requiring a primary total knee replacement.
Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
Patients with intact collateral ligaments.
Patients with inflammatory arthritis.
Patients that are morbidly obese, body mass index (BMI) > 40.
Patients with a history of total or unicompartmental reconstruction of the affected joint.
Patients that have had a high tibial osteotomy or femoral osteotomy.
Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
Patients that are immunologically compromised, or receiving chronic steroids (>30 days).
Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
Patients with knee fusion to the affected joint.
Patients with an active or suspected latent infection in or about the knee joint.
Patients that computer-assisted surgical navigation (CAOS) techniques will be used.
Patients that minimally invasive surgical technique will be used.