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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Osteoarthritis / Knee Replacement
Title   Post-Market Study of total knee replacement system (3DKnee System) (Orthopedics / Knee Replacement)
Description   The purpose of this study is to evaluate the use and efficacy of the 3DKnee System for total knee replacement surgery. This is a prospective data collection study and the data will be collected before, during and after surgery.
IRB Number   Pro2109
Inclusion/Notes   INCLUSION:
  • This must be a primary knee replacement on this knee.

  • The subject must have joint disease realted to one or more of the following:
    degenerative joint disease, including osteoarthritis or traumatic arthritis
    avascular necrosis ofthe femoral condyles,
    post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfuction or prio patellectomy,
    moderate valgus, varus, or flexion deformities,
    rheumatoid arthritis.

  • Subject is likely to be available for evaluation for the duration of the study.

  • Able and willing to sign the informed consent and follow study procedures.

  • Subject is not pregnant.

EXCLUSION:
  • Subject is younger than 18 years of age.

  • Subject has had a total knee replacement on this knee in the past.

  • Infection, or history of infection, acute or chronic, local or systemic.

  • Alcoholism or other addictions.

  • Muscular, neurological or vascular deficiencies which compromise the affected extremity.

  • Obesity.

  • Insufficient bone quality.

  • Loss of ligamentous structures.

  • High levels of physical activity.

  • Materials sensitivity.

  • Subject is a prisoner.

  • Subject is pregnant.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Hospital Plano
Principal Name    Richard David Reitman MD
Contact Name   Shelley Long
Phone   (214) 345-8131

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