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Clinical Outcomes With Omni Apex Ultracongruent Knee System

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ClinicalTrials.gov Identifier: NCT01367938
Recruitment Status : Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Device: OMNI Apex Ultracongruent Knee Device

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: OMNI Apex Knee Ultracongruent vs. Triathlon® Posterior Stabilized & Cruciate Substituting Outcomes Study
Study Start Date : November 2009
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing total knee replacement
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367938


Locations
United States, Washington
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Spokane Joint Replacement Center
Investigators
Principal Investigator: David F Scott, MD Spokane Joint Replacement Center

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01367938     History of Changes
Other Study ID Numbers: SJRC-OK
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Osteoarthritis
Total Knee Replacement
Total Knee Arthroplasty
TKA
Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases