Antero-Posterior Knee Stability

NCT ID: NCT03387839

Last Updated: 2018-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Osteoarthritis Total Knee Arthroplasty Stability Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Medial-Pivot Knee Prosthesis

Stress X-Ray

Intervention Type OTHER

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

Stress X-Ray

Intervention Type OTHER

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

Stress X-Ray

Intervention Type OTHER

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

Interventions

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Stress X-Ray

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David F. Scott, MD

OTHER

Sponsor Role lead

Responsible Party

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David F. Scott, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David F Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Spokane Joint Replacement Center

Locations

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Spokane Joint Replacement Center

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SJRC-AP-Stability

Identifier Type: -

Identifier Source: org_study_id

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