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
100 participants
OBSERVATIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Medial-Pivot Knee Prosthesis
Stress X-Ray
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Posterior-Stabilized Knee Prosthesis
Stress X-Ray
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Cruciate-Stubstituting Knee Prosthesis
Stress X-Ray
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Interventions
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Stress X-Ray
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Eligibility Criteria
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Inclusion Criteria
* Patients able to comply with study requirements including stress x-rays and self-evaluations.
* Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
* Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
* Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
* Patients with intact collateral ligaments.
* Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.
Exclusion Criteria
* Patients that are morbidly obese, body mass index (BMI) \> 40.
* 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), excluding inhalers.
* 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 are prisoners.
21 Years
80 Years
ALL
No
Sponsors
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David F. Scott, MD
OTHER
Responsible Party
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David F. Scott, MD
Principal Investigator
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-AP-Stability
Identifier Type: -
Identifier Source: org_study_id
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