This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Total knee replacement for revision cases
The CORE Institute
Phoenix, Arizona, United States
Heekin Institute for Orthopedic Research
Jacksonville, Florida, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Time frame: pre-op, 2 years
Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
Time frame: 2 years, 5 years
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to \> 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes. AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm. ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and \> 5mm) at 2 years and 5 years with all results in only one category of \< 5 degrees. The higher the number of degrees or mm measured the more instability in the knee.
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Tufts Medical Center
Boston, Massachusetts, United States
Rothman Institute
Egg Harbor, New Jersey, United States
Ridgewood Orthopedics
Ridgewood, New Jersey, United States
Upstate Bone and Joint Center
East Syracuse, New York, United States
University of North Carolina Orthopedics
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wellington Orthopaedic & Sports Medicine
Cincinnati, Ohio, United States
...and 2 more locations
Time frame: 2 year and 5 year postoperative
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to \> 5mm. Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
Time frame: 2 year and 5 year postoperative
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: pre-op, 1, 2, 5 years
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters. The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
Time frame: 1, 2, 5 years
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
Time frame: 5 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Time frame: pre-op, 1, 2, 5 years
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
Time frame: pre-op, 1, 2, 5 years
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: pre-op, 1, 2, 5 years
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Time frame: pre-op, 1,2, 5 year