Post Market Study of the 3DKnee™ With E-plus Insert (e-plus)
The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.
Degenerative Joint Disease
Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Multicenter Open Label Study Examining the Mid- and Long-term Safety and Efficacy of the 3DKnee™ System With Vitamin E UHMWPE Tibial Inserts (3DKnee™ With E-plus Insert)|
- Efficacy of the Vitamin E UHMWPE as part of the total knee system, measured by Knee Society Score Evaluation and total number of radiologic failures of the device. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
The (American) Knee Society Score has both an objective and a functional component. The objective score takes into account pain, flexion, stability, alignment, extension lag and flexion contracture. Overall success will be defined as a KSS score ≥ 80 at two years.
Radiolucencies have been defined as two types, with one type being more common than the other. In the case of physiologic radiolucency, which is the most common type of radiolucency seen, there is a narrow line present that is well-defined around the prosthesis. This line is surrounded by a radio-dense line and tends to consolidate (disappear) within the first year. The second type of radiolucency, the pathologic radiolucency, is rarer and is associated with loosening and infection. It is a progressive, poorly defined radiolucency that is more than 2 mm thick and without a radiolucent line.
- Change in Knee Society Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]The Knee Society Score includes a knee rating and function score. This evaluation covers the knee rating score with three main parameters of pain, stability and range of motion and that flexion contracture, extension lag and misalignment should be dealt with as deductions. Thus, 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability. 50 points are allotted for pain, 25 for stability, and 25 for range of motion. Grading for KS Score: Excellent (90-100), Good (80-90), Fair (70-79) and Poor (<70).
- Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]The Western Ontario McMaster Arthritis Index is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It can be self-administered. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability.
- Change in Oxford Knee Score from pre-surgery to 10 years [ Time Frame: 10 year ] [ Designated as safety issue: No ]The Oxford Knee Score (OKS) is a patient-based outcomes measure consisting of 12 questions that is sensitive, simple and validated. It is based on a maximum score of 48.
- Change in response to Quality of Life questions from pre-surgery to 6 months and each year thereafter through 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- 6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years [ Time Frame: 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||June 2024|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
3DKnee™ with e-plus Insert
Subjects who meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE) and who are candidates for a primary knee arthroplasty.
Device: 3DKnee™ System with Vitamin E UHMWPE Tibial Inserts
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
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. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551472
|Contact: Beth LG Brakewood, MPHfirstname.lastname@example.org|
|United States, Alabama|
|Mobile, Alabama, United States, 36693|
|United States, Arizona|
|Valley Bone & Joint Specialists||Recruiting|
|Mesa, Arizona, United States, 85206|
|Principal Investigator: Salvatore G Lacognata, D.O.|
|United States, California|
|Orthopaedic Surgery Specialists||Recruiting|
|Burbank, California, United States, 91505|
|Principal Investigator: Shahan V Yacoubian, M.D.|
|Sub-Investigator: Stephan V. Yacoubian, M.D.|
|Orthopedic Specialists of North County||Recruiting|
|Oceanside, California, United States, 92056|
|Principal Investigator: James Helgager, M.D.|
|United States, Colorado|
|Colorado Orthopedic Consultants, PC||Recruiting|
|Englewood, Colorado, United States, 80110|
|Principal Investigator: Jeffrey A. Arthur, D.O.|
|United States, Florida|
|Coastal Orthopedics & Sports Medicine||Withdrawn|
|Bradenton, Florida, United States, 34209|
|Institute for Orthopaedic Surgery and Sports Medicine||Recruiting|
|Fort Myers, Florida, United States, 33919|
|Principal Investigator: George D. Markovich, M.D., FACS|
|Miami, Florida, United States, 33133|
|Florida Orthopaedic Institute||Withdrawn|
|Temple Terrace, Florida, United States, 33637|
|United States, Maryland|
|Baltimore, Maryland, United States, 21209|
|United States, Missouri|
|St. Peter's Bone & Joint Surgery||Recruiting|
|St. Peters, Missouri, United States, 63376|
|Principal Investigator: John W. McAllister, M.D.|
|United States, New Mexico|
|New Mexico Orthopedics||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator: Joshua T. Carothers, M.D.|
|Sub-Investigator: Krishna R. Tripuraneni, M.D.|
|United States, New York|
|NYU Hospital for Joint Diseases||Not yet recruiting|
|New York, New York, United States, 10003|
|Principal Investigator: Claudette LaJam, M.D.|
|United States, Texas|
|Texas Institute for Hip and Knee Surgery||Recruiting|
|Austin, Texas, United States, 78751|
|Principal Investigator: David A. Dodgin, M.D.|
|Sub-Investigator: Eric M. Heinrich, M.D.|