NCT00765362|CompletedPhase 3Results
Mobile - Bearing Knee Study
Encore Mobile - Bearing Knee Study #200
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Sponsor study identifier
interventional
419
1 country
8
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)To evaluate the safety and efficacy of the Encore Mobile-Bearing Knee.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
June 2008
Actual (reported)August 2008
Actual (reported)September 30, 2008
Actual (reported)October 2, 2008
Actual (reported)April 19, 2011
Actual (reported)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).
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.
Subjects who are candidates for a total knee replacement and meet the inclusion/exclusion criteria of the study.
Used for primary total knee replacement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Carl T. Hayden VA Hospital
Phoenix, Arizona, 85012, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708, United States
S.Florida VA Found. For Research & Education, Inc.
Miami, Florida, 33125, United States
Great Lakes Orthopaedics
Garden City, Michigan, 48135, United States
Hilton Head Island, South Carolina, 29926, United States
Orthopedic Surgery Center and Sports Medicine
Edinburg, Texas, 78539, United States
The Orthopedic Specialty Hospital
419 participants (actual enrollment reported by the registry).
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
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.
2 year
Contact the study team to confirm eligibility.
Murray, Utah, 84107, United States
West Jordan, Utah, 84084, United States
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
May 11, 2011
Results First Posted
April 19, 2011
Record last verified: 2011-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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