Clinical Outcomes With Omni Apex Ultracongruent Knee System

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: OMNI Apex Ultracongruent Knee Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OMNI Apex Ultracongruent Knee Device<br> | Device: OMNI Apex Ultracongruent Knee Device<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | Clinical outcomes to include overall success, revision rate, adverse events, clinical score (Knee Society Score), range of motion, radiographic findings. | Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Total Knee Replacement, Total Knee Arthroplasty, TKA, Knee