Clinical Outcomes With Omni Apex Ultracongruent Knee System
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.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01367938
Active, not recruiting
: 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
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.
Ages Eligible for Study:
21 Years to 80 Years (Adult, Senior)
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.