Status:
COMPLETED
Post-Market Study of the 3DKnee™ System
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Degenerative Joint Disease
Osteoarthritis
Eligibility:
All Genders
18+ years
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00819481
Start Date
February 1 2009
End Date
October 1 2018
Last Update
March 16 2021
Active Locations (8)
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1
Longo Orthopedics
Scottsdale, Arizona, United States, 85251
2
Center for Excellence
Fresno, California, United States, 93710
3
OrthoMaryland
Baltimore, Maryland, United States, 21209
4
Metro Orthopedics and Sports Therapy
Silver Spring, Maryland, United States, 20910