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OpenTrials
Completed

NCT Number: NCT01367938

Clinical Outcomes With Omni Apex Ultracongruent Knee System

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMNI Apex Ultracongruent Knee Device

Device

Primary outcomes

  1. Clinical outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spokane Joint Replacement Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2011
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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