Clinical Outcomes With Omni Apex Ultracongruent Knee System

Completed

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT01367938

Run by

Spokane Joint Replacement Center

People needed

69

Starts

2009-11-01

Expected to finish

2018-12-01

Last updated by the study team

2018-12-05

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Spokane Joint Replacement Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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