Post-Market Study of the 3DKnee™ System

Completed

Conditions studied: Degenerative Joint Disease, Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

In brief

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

Key facts

Study ID

NCT00819481

Run by

Encore Medical, L.P.

People needed

229

Starts

2009-02-01

Expected to finish

2018-10-01

Last updated by the study team

2021-03-16

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.
• 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

You may not qualify if…

• 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

Where it is running

• Longo Orthopedics — Scottsdale, Arizona, United States
• Center for Excellence — Fresno, California, United States
• OrthoMaryland — Baltimore, Maryland, United States
• Metro Orthopedics and Sports Therapy — Silver Spring, Maryland, United States
• Leslie Orthopedics and Sports Medicine — Camdenton, Missouri, United States
• St. Peter's Bone & Joint Surgery — City of Saint Peters, Missouri, United States
• Texas Center for Joint Replacement — Plano, Texas, United States
• Rimrock Orthopedics — St. George, Utah, United States

Full record on ClinicalTrials.gov

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