Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study

David F. Scott, MD1 site in 1 country100 target enrollmentJanuary 2016

ConditionsOsteoarthritis Total Knee Arthroplasty Stability Knee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: David F. Scott, MD
Enrollment: 100
Locations: 1
Primary Endpoint: Measurement of antero-posterior stability of the knee with stress x-rays.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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. Multiple implant brand/models will be included in the study.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

December 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

David F. Scott, MD

Responsible Party

Sponsor Investigator

Principal Investigator

David F. Scott, MD

Principal Investigator

Spokane Joint Replacement Center

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•Patients with inflammatory arthritis.
•Patients that are morbidly obese, body mass index (BMI) \>
•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.

Outcomes

Primary Outcomes

Measurement of antero-posterior stability of the knee with stress x-rays.

Time Frame: 1 year post-operative

Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion. Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.