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Completed

NCT Number: NCT03387839

Antero-Posterior Knee Stability

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis, Knee Rheumatic Diseases Stability Total Knee Arthroplasty

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stress X-Ray

Other

Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

David F. Scott, MD

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 2, 2018
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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