Antero-Posterior Knee Stability
- Conditions
- Total Knee ArthroplastyOsteoarthritisKnee OsteoarthritisStability
- Interventions
- Other: Stress X-Ray
- Registration Number
- NCT03387839
- Lead Sponsor
- David F. Scott, MD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Posterior-Stabilized Knee Prosthesis Stress X-Ray - Medial-Pivot Knee Prosthesis Stress X-Ray - Cruciate-Stubstituting Knee Prosthesis Stress X-Ray -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Spokane Joint Replacement Center
🇺🇸Spokane, Washington, United States