This trial is active, not recruiting.

Conditions degenerative joint disease, osteoarthritis, rheumatoid arthritis, traumatic arthritis
Treatment 3dknee™ system
Phase phase 4
Sponsor Encore Medical, L.P.
Start date February 2009
End date January 2014
Trial size 300 participants
Trial identifier NCT00819481, PS - 700


The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Post Market Study
3dknee™ system
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.

Primary Outcomes

efficacy of total knee system
time frame: 2 year

Secondary Outcomes

change in Knee Society Score
time frame: 5 year
change in pain from pre-op to post-op
time frame: 5 year
patient satisfaction
time frame: 5 year
change in WOMAC Osteoarthritis Index from pre-surgery
time frame: 5 year
change in Oxford Knee Score from pre-surgery
time frame: 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Post-Market Study of the 3DKnee™ System Protocol No. PS -- 700
Principal investigator John W. McAllister, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Encore Medical, L.P..