Status:
COMPLETED
Antero-Posterior Knee Stability
Lead Sponsor:
David F. Scott, MD
Conditions:
Osteoarthritis
Total Knee Arthroplasty
Eligibility:
All Genders
21-80 years
Brief Summary
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. ...
Eligibility Criteria
Inclusion
- Patients willing to sign the informed consent.
- 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
- Patients with inflammatory arthritis.
- 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.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03387839
Start Date
January 1 2016
End Date
December 1 2017
Last Update
January 2 2018
Active Locations (1)
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1
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218