Clinical Outcomes With Omni Apex Ultracongruent Knee System

Spokane Joint Replacement Center

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: OMNI Apex Ultracongruent Knee Device

Study type: Observational

Funder types: Other

Identifiers

NCT01367938

SJRC-OK

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

69 participants in 1 patient group

OMNI Apex Ultracongruent Knee Device

Treatment:

Device: OMNI Apex Ultracongruent Knee Device