The 3DKnee™ System: A Post-Market Study

Completed · Phase 4

Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Post Traumatic Arthritis, Varus Deformity, Avascular Necrosis

In brief

The purpose of this study is to evaluate the survivorship and efficacy of the Encore 3DKnee™ system in a group of patients who will receive the 3DKnee™ as a primary (first) orthopedic implant in the knee. Each knee will be designated as a separate subject and followed for a period of 2 years.

Key facts

Study ID

NCT00764673

Run by

Encore Medical, L.P.

People needed

71

Starts

2006-10-01

Expected to finish

2010-10-01

Last updated by the study team

2011-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• This must be a primary knee replacement on this knee.
• 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
• Patient must be over 18 years of age

You may not qualify if…

• 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
• Is younger than 18 years of age

Where it is running

• St. Peter's Bone & Joint Surgery — City of Saint Peters, Missouri, United States

Full record on ClinicalTrials.gov

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