Clinical Outcomes With Omni Apex Ultracongruent Knee System

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01367938

Enrollment

Registered

2011-06-07

Start date

2009-11-30

Completion date

2018-12-31

Last updated

2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Total Knee Replacement, Total Knee Arthroplasty, TKA, Knee

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.

Interventions

DEVICEOMNI Apex Ultracongruent Knee Device

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026