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 |
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.
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.
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