Clinical Outcomes With Omni Apex Ultracongruent Knee System
NCT ID: NCT01367938
Last Updated: 2018-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
69 participants
OBSERVATIONAL
2009-11-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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OMNI Apex Ultracongruent Knee Device
OMNI Apex Ultracongruent Knee Device
Interventions
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OMNI Apex Ultracongruent Knee Device
Eligibility Criteria
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Inclusion Criteria
* 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 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.
21 Years
80 Years
ALL
Yes
Sponsors
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Spokane Joint Replacement Center
OTHER
Responsible Party
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David F. Scott, MD
PI
Principal Investigators
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David F Scott, MD
Role: PRINCIPAL_INVESTIGATOR
Spokane Joint Replacement Center
Locations
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Spokane Joint Replacement Center
Spokane, Washington, United States
Countries
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Other Identifiers
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SJRC-OK
Identifier Type: -
Identifier Source: org_study_id
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