Clinical Outcomes With Omni Apex Ultracongruent Knee System

December 4, 2018 updated by: David F. Scott, MD, Spokane Joint Replacement Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients undergoing total knee replacement

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OMNI Apex Ultracongruent Knee Device
Device: OMNI Apex Ultracongruent Knee Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spokane Joint Replacement Center

Investigators

  • Principal Investigator: David F Scott, MD, Spokane Joint Replacement Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 22, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJRC-OK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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