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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon TS Knee | Other | Triathlon TS Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon TS Knee System | Device | Total knee replacement for revision cases |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | pre-op, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirby D Hitt, M.D. | Scott & White Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute | Phoenix | Arizona | 85023 | United States | ||
| Heekin Institute for Orthopedic Research |
226 participants/228 knees were enrolled in the study. 47 participants/47 knees were censored from the main cohort. One bilateral participant had one knee censored and one knee included in study so this participant counts in the total. Therefore, 180 participants/181 knees are followed and applicable data is reflected in this record.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon TS Knee | Triathlon TS Knee System: Total knee replacement for revision cases |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were censored are not included in baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon TS Knee | Triathlon TS Knee System: Total knee replacement for revision cases |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 2 years | knees | knees |
|
This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.
Specific Adverse Event terms not used for all Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operative Adverse Events | Triathlon TS Knee System: Total knee replacement for revision cases Operative site events are reported by knee because in the case of bilateral participants (this is when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately for this reason. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Axelson, Director, Clinical Operations | Stryker Orthopaedics | 201-831-5401 | ellen.axelson@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2013 | May 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2008 | May 15, 2020 | ICF_001.pdf |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | pre-op, 1,2, 5 year |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Rothman Institute | Egg Harbor | New Jersey | 08234 | United States |
| Ridgewood Orthopedics | Ridgewood | New Jersey | 07450 | United States |
| Upstate Bone and Joint Center | East Syracuse | New York | 13057 | United States |
| University of North Carolina Orthopedics | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
| Wellington Orthopaedic & Sports Medicine | Cincinnati | Ohio | 45255 | United States |
| The Orthopaedic Center | Tulsa | Oklahoma | 74120 | United States |
| Scott & White Clinic | Temple | Texas | 76508 | United States |
| No 2 yr. Knee Society Score data |
|
| 2 yr. Knee Society Score not calculable |
|
| Subject terminated |
|
| Revision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Triathlon TS Knee System: Total knee replacement for revision cases |
|
|
|
| Secondary | 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. | Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative. | Posted | Mean | Standard Deviation | units on a scale | 2 years, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative. | Posted | Number | Knees | 2 year and 5 year postoperative | Knees | Knees |
|
|
|
| Secondary | 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. | Data based on knees with available radiographic and clinical data at 2 years and 5 years postoperative. There was an one more anterior knee pain evaluation as compared to knee stability and KSS Function as there was one missing value on those two evaluations. | Posted | Number | Knees | 2 year and 5 year postoperative | Knees | Knees |
|
|
|
| Secondary | 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. | Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 1, 2, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Data based on knees with available data at 1, 2 and 5 years postoperative at the tibial and femoral component interface. | Posted | Number | Knees | 1, 2, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Knees enrolled in the study. | Posted | Number | Knees | 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Knees with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 1, 2, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 1, 2, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Participants/knees with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 1, 2, 5 years | Knees | Knees |
|
|
|
| Secondary | 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. | Data based on knees with available data at 1,2 and 5 years postoperative. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 1,2, 5 year | Knees | Knees |
|
|
|
| 0 |
| 181 |
| 37 |
| 181 |
| 59 |
| 181 |
| EG001 | Non-Operative Adverse Events | Triathlon TS Knee System: Total knee replacement for revision cases Non-Operative Site Events are reported by participant. | 7 | 180 | 40 | 180 | 0 | 180 |
| Non-operative Site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative site | General disorders | Non-systematic Assessment |
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| Operative Site | Infections and infestations | Non-systematic Assessment |
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| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Non-operative Site | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Non-operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Non-operative Site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Non-operative Site | Nervous system disorders | Non-systematic Assessment |
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| Non-operative Site | Psychiatric disorders | Non-systematic Assessment |
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| Non-operative Site | Renal and urinary disorders | Non-systematic Assessment |
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| Non-operative Site | Reproductive system and breast disorders | Non-systematic Assessment |
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| Non-operative Site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Non-operative Site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Non-operative Site | Social circumstances | Non-systematic Assessment |
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| Non-operative Site | Vascular disorders | Non-systematic Assessment |
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| Non-operative Site | Infections and infestations | Non-systematic Assessment |
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| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Operative Site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Operative Site | Nervous system disorders | Non-systematic Assessment |
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| Operative Site | Renal and urinary disorders | Non-systematic Assessment |
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| Non-operative Site | Blood and lymphatic system disorders | Non-systematic Assessment |
|
Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts & abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
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| KSS Function Score at 5yr |
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| Knee Stability AP 5-10mm at 2 years |
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| Knee Stability AP < 5mm at 5 years |
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| Knee Stability AP 5-10mm at 5 years |
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| Knee Stability ML< 5 degrees at 2 years |
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| Knee Stability ML < 5 degrees at 5 years |
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| Anterior Knee Pain Present at 2 yrs. |
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| Anterior Knee Pain Absent at 5 yrs. |
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| Anterior Knee Pain Present at 5 yrs. |
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| SF-36 Physical Score 1 year |
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| SF-36 Physical Score 2 year |
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| SF-36 Physical Score 5 year |
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| SF-36 Mental Score Preoperative |
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| SF-36 Mental Score 1 year |
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| SF-36 Mental Score 2 year |
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| SF-36 Mental Score 5 years |
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| Radiographically unstable at 2 year |
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| Radiographically unstable at 5 year |
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| KOOS Pain 1 year |
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| KOOS Pain 2 year |
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| KOOS Pain 5 year |
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| KOOS Symptoms Preoperative |
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| KOOS Symptoms 1 year |
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| KOOS Symptoms 2 year |
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| KOOS Symptoms 5 year |
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| KOOS Daily Living Preoperative |
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| KOOS Daily Living 1 year |
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| KOOS Daily Living 2 year |
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| KOOS Daily Living 5 year |
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| KOOS Function Sports and Recreational Preoperative |
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| KOOS Function Sports and Recreational 1 year |
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| KOOS Function Sports and Recreational 2 year |
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| KOOS Function Sports and Recreational 5 year |
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| KOOS Quality of Life Preoperative |
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| KOOS Quality of Life 1 year |
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| KOOS Quality of Life 2 year |
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| KOOS Quality of Life 5 year |
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| HSS Patella Score 1 year |
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| HSS Patella Score 2 year |
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| HSS Patella Score 5 year |
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| LEAS Score 1 year |
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| LEAS Score 2 year |
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| LEAS Score 5 year |
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| Pain Motion Mean 1 year |
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| Pain Motion Mean 2 year |
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| Pain Motion Mean 5 year |
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| Function Mean Preoperative |
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| Function Mean 1 year |
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| Function Mean 2 year |
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| Function Mean 5 year |
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