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Antero-Posterior Knee Stability

D

David F. Scott, MD

Status

Completed

Conditions

Osteoarthritis
Knee Osteoarthritis
Stability
Total Knee Arthroplasty

Treatments

Other: Stress X-Ray

Study type

Observational

Funder types

Other

Identifiers

NCT03387839
SJRC-AP-Stability

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 3 patient groups

Medial-Pivot Knee Prosthesis
Treatment:
Other: Stress X-Ray
Posterior-Stabilized Knee Prosthesis
Treatment:
Other: Stress X-Ray
Cruciate-Stubstituting Knee Prosthesis
Treatment:
Other: Stress X-Ray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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