Status:
COMPLETED
The 3DKnee™ System: A Post-Market Study
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 k...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00764673
Start Date
October 1 2006
End Date
October 1 2010
Last Update
March 2 2011
Active Locations (1)
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1
St. Peter's Bone & Joint Surgery
City of Saint Peters, Missouri, United States, 63376