The 3DKnee™ System: A Post-Market Study
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 knee. Each knee will be designated as a separate subject and followed for a period of 2 years.
Post Traumatic Arthritis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The 3DKnee™ System: A Post-Market Study|
- Knee Society Score Evaluation [ Time Frame: 2 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).
- Knee Society Function Score [ Time Frame: 2-year ] [ Designated as safety issue: No ]The Knee Society Score includes a knee rating and function score. Patient function considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score, which is also 100, is obtained by a patient who can walk an unlimited distance and go up and down stairs normally. Walking ability is expressed in blocks (approximately 100 meters). Stair climbing is considered normal if the patient can ascend and descend stairs without holding a railing. A score of > or = to 60 on the function score is considered success.
- Number of Participants With >2mm Wide at the Bone/Cement Interface or a >3 Degree or >3 mm Migration (Shift) of the Component. [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]Radiographic failure is defined as a complete radiolucent line > 2mm wide at the bone/cement interface or a >3 degree or >3 mm migration (shift) of the component.
- Safety Assessment [ Time Frame: 2-year ] [ Designated as safety issue: Yes ]Number of device related adverse events and device failures at the 2 year time frame.
- Oxford Knee Score [ Time Frame: 2-year ] [ Designated as safety issue: No ]Questionnaire on the perceptions of patients about a total knee replacement. Score between 0 and 48 where: 0 to 19 may indicate severe knee arthritis, 20 to 29 may indicate moderate to severe knee arthritis, 30 to 39 may indicate mild to moderate knee arthritis and 40 to 48 may indicate satisfactory joint function.
|Study Start Date:||October 2006|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Post market study
Subjects with knee osteoarthritis and willing to participate in the study
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764673
|United States, Missouri|
|St. Peter's Bone & Joint Surgery|
|St. Peters, Missouri, United States, 63376|
|Principal Investigator:||John McAllister, M.D.||St. Peter's Bone and Joint Surgery|