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Antero-Posterior Knee Stability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387839
Recruitment Status : Completed
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis Total Knee Arthroplasty Stability Knee Osteoarthritis Other: Stress X-Ray

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
Actual Study Start Date : January 2016
Primary Completion Date : December 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Knee Society Score (KSS) [ Time Frame: 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.

  2. Lower Extremity Activity Scale (LEAS) [ Time Frame: 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.

  3. Forgotten Joint Score (FJS) [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Internal database of prior total knee replacement patients.
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) > 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387839


Locations
United States, Washington
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218
Sponsors and Collaborators
David F. Scott, MD
Investigators
Principal Investigator: David F Scott, MD Spokane Joint Replacement Center
More Information

Responsible Party: David F. Scott, MD, Principal Investigator, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT03387839     History of Changes
Other Study ID Numbers: SJRC-AP-Stability
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases