In This SectionTexas 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.
