To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
419
Used for primary total knee replacement
Carl T. Hayden VA Hospital
Phoenix, Arizona, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
S.Florida VA Found. For Research & Education, Inc.
Miami, Florida, United States
Great Lakes Orthopaedics
Garden City, Michigan, United States
Knee Society Score Evaluation
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: 2 year
Knee Society Function Score
The patient function score considers only walking distance and stair climbing, with deductions for walking aids. The maximum function score 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. Minimum score = 0, maximum score = 100 with the higher the score representing a better outcome.
Time frame: 2 year
Knee Society Scores Used as Success/Failure Criteria.
The maximum score for each of the sections is 100 points. A score of at least 80 points on the 2-year knee assessment score was defined as a success.
Time frame: 2 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Hilton Head Island, South Carolina, United States
Orthopedic Surgery Center and Sports Medicine
Edinburg, Texas, United States
The Orthopedic Specialty Hospital
Murray, Utah, United States
Unnamed facility
West Jordan, Utah, United States