An observational study in Degenerative Joint Disease, Osteoarthritis and Traumatic Arthritis, sponsored by Encore Medical, L.P.. Terminated at 6 sites in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Encore Medical, L.P. · Observational
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.
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).
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 175 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Encore Medical, L.P. is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must be diagnosed with either osteoarthritis or traumatic arthritis and be candidates for a primary total knee arthroplasty. They must also meet the indications for use for the 3DKnee system with the vitamin E tibial insert.
Exclusion Criteria:
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.
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.
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.
Time frame: 2 year
Change in Knee Society Score from pre-surgery to 10 years
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).
Time frame: 10 year
Change in WOMAC Osteoarthritis Index from pre-surgery to 10 years
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.
Time frame: 10 year
Change in Oxford Knee Score from pre-surgery to 10 years
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.
Time frame: 10 year
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
6. Change in pain from pre-surgery to 6 months and each year thereafter through 10 years
Time frame: 10 years
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Encore Medical, L.P.