Clinical Outcomes With Omni Apex Ultracongruent Knee System



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:21 - 80
Updated:12/7/2018
Start Date:November 2009
End Date:December 2018

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OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study

A prospective, matched case comparison of total knee arthroplasty with the OMNI Apex
Ultracongruent vs. Triathlon® CS tibial insert vs. the Triathlon® PS tibial insert.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- Patients that are prisoners.
We found this trial at
1
site
Spokane, Washington 99218
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Spokane, WA
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