Antero-Posterior Knee Stability

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Knee Osteoarthritis; Total Knee Arthroplasty; Stability
• Intervention / Treatment: Other: Stress X-Ray

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99218
      • Spokane Joint Replacement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Internal database of prior total knee replacement patients.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medial-Pivot Knee Prosthesis	Other: 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	Other: 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	Other: Stress X-Ray; Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of antero-posterior stability of the knee with stress x-rays.	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.	1 year post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score (KSS)	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.	1 year post-operative
Lower Extremity Activity Scale (LEAS)	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.	1 year post-operative
Forgotten Joint Score (FJS)	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.	1 year post-operative

Collaborators and Investigators

• Sponsor: David F. Scott, MD
• Investigators: Principal Investigator: David F Scott, MD, Spokane Joint Replacement Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 29, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SJRC-AP-Stability

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No