The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System for total knee replacement surgery.
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.
Study Type
OBSERVATIONAL
Enrollment
229
Total knee replacement joint for subjects with knee osteoarthritis and willing to participate in the study.
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
efficacy of total knee system
Time frame: 2 year
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
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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