Degenerative Joint Disease, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Keywords
Total knee replacement
Brief summary
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
Detailed description
Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery. The study will take place at multiple sites across the United States and be managed by the Encore Medical Clinical Affairs Department. The study will include only patients who meet the indications for use criteria for the 3DKnee™ System and who are candidates for primary knee arthroplasty.
Interventions
DEVICE3DKnee™ System
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
Sponsors
Encore Medical, L.P.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* This must be a primary knee replacement on this knee. * Patient is over 18 years of age or older * Have knee joint disease related to one or more of the following * degenerative joint disease, including osteoarthritis or traumatic arthritis * Avascular necrosis of the femoral condyles * Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy * Moderate valgus, varus, or flexion deformities * Rheumatoid arthritis * Patient 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 * Patient is not pregnant
Exclusion criteria
* Is younger than 18 years of age * If there has been a total knee replacement on this knee in the past (no revisions allowed in study) * 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 * Prisoner * Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements * Patient is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of total knee system | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| change in Knee Society Score | 5 year |
| change in pain from pre-op to post-op | 5 year |
| patient satisfaction | 5 year |
| change in WOMAC Osteoarthritis Index from pre-surgery | 5 year |
| change in Oxford Knee Score from pre-surgery | 5 year |
Countries
United States
Outcome results
None listed