Knee Osteoarthritis, Osteoarthritis, Stability, Total Knee Arthroplasty
Conditions
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.
Interventions
OTHERStress X-Ray
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Sponsors
David F. Scott, MD
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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) \> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of antero-posterior stability of the knee with stress x-rays. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score (KSS) | 1 year post-operative | Clinical outcomes will be evaluated via the Knee Society Score (KSS) obtained during a single visit for subjects 1 year or greater post-operatively. The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome. |
| Lower Extremity Activity Scale (LEAS) | 1 year post-operative | Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS) obtained during a single visit for subjects 1 year or greater post-operatively. The LEAS scale range is 1-18, with a higher value indicating a higher level of activity. |
| Forgotten Joint Score (FJS) | 1 year post-operative | Clinical outcomes will be evaluated via the Forgotten Joint Score (FJS) obtained during a single visit for subjects 1 year or greater post-operatively. The FJS total score range is 0-100, with higher scores indicating a higher degree of forgetting the artificial joint, that is, a lower degree of awareness. |
Countries
United States
Outcome results
None listed