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The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.
The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon® CR Total Knee System | Other | Participants receive the Triathlon® CR Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon® CR Total Knee System | Device | The purpose is to evaluate the Triathlon® CR Total Knee System. |
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| Measure | Description | Time Frame |
|---|---|---|
| Active Range of Motion | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Society Score (KSS) Over Time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knute Buehler, MD | The Center: Orthopaedic & Neurosurgical Care & Research | Principal Investigator |
| Brian Covino, MD | Knoxville Orthopedic Clinic | Principal Investigator |
| Joseph Davies, MD | Aurora Advanced Healthcare | Principal Investigator |
| Kenneth Greene, MD | Crystal Clinic | Study Chair |
| Anthony Hedley, MD | Arizona Institute for Bone and Joint Disorders | Principal Investigator |
| Kirby Hitt, MD | Scott & White Memorial Hospital | Principal Investigator |
| Joseph McCarthy, MD | Newton-Wellesley Hospital | Principal Investigator |
| Jeffrey Nassif, MD | Physician's Clinic of Iowa, PC | Principal Investigator |
| Kenneth Krackow, MD | Buffalo General Hospital, Department of Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Institute for Bone and Joint Disorders | Phoenix | Arizona | 85016 | United States | ||
| Cedars Medical Center University of Miami |
467/500 participants/knees enrolled;56 participants/60 knees censored = 411/440 participants/knees followed
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon® CR Total Knee System | Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| preoperative, 1, 2, and 5 years |
| Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion. | 1, 2, and 5 years |
| Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. | 1, 2, and 5 years |
| Change in SF-36 Health Survey Over Time | 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. | preoperative, 1, 2, 3, 4, and 5 years |
| Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes. | preoperative,1, 2, 3, 4 and 5 years |
| Change in Lower-Extremity Activity Scale (LEAS) Over Time | 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. | preoperative, 1, 2, 3, 4, and 5 years |
| Patellar Subluxation, Dislocation and Fracture Rate | The incidence of patellar subluxation, dislocation or fracture is reported. | 5 years |
| Patient Outcome Long Term Follow-up Questionnaire Over Time | Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:
| 6, 7, 8, 9, and 10 years |
| Implant Survivorship | Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method. | 10 years |
| Sean Scully, MD |
| Cedars Medical Center University of Miami |
| Principal Investigator |
| Carlton Savory, MD | Hughston Sports Medicine Center | Principal Investigator |
| Mathew Phillips, MD | Buffalo General Hospital, Department of Orthopaedics | Principal Investigator |
| Miami |
| Florida |
| 33136 |
| United States |
| Hughston Sports Medicine Center | Columbus | Georgia | 31908 | United States |
| Physician's Clinic of Iowa, Mercy Medical Center | Cedar Rapids | Iowa | 52401 | United States |
| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Buffalo General Hospital, Department of Orthopaedics Kaleida Health | Buffalo | New York | 14203 | United States |
| Crystal Clinic | Akron | Ohio | 44330 | United States |
| The Center: Orthopaedic & Neurosurgical Care & Research | Bend | Oregon | 97701 | United States |
| Knoxville Orthopaedic Clinic | Knoxville | Tennessee | 37909 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Aurora Advanced Healthcare | Milwaukee | Wisconsin | 53233 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon® CR Total Knee System | Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Active Range of Motion | Participants/knees with available data. | Posted | Mean | Standard Deviation | Degrees | 2 Years | knees | knees |
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| Secondary | Change in Knee Society Score (KSS) Over Time | 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. | 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 | preoperative, 1, 2, and 5 years | knees | knees |
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| Secondary | Active Flexion, Passive Flexion, Active Extension, and Passive Extension Range of Motion (ROM) | Knee range of motion is measured by the number of degrees flexion and extension observed. Active motion is the number of degrees that a participant can extend and flex their knee independently. Passive motion is the number of degrees that an examiner is able to extend and flex the knee without the assistance of the participant. The Knee Society Score range of motion utilized for this study defines the range from 0 degrees of extension to 125 degrees of flexion. | Participants/knees with available data. Overall number of participants and units analyzed is based upon preoperative population. | Posted | Mean | Standard Deviation | degrees | 1, 2, and 5 years | knees | knees |
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| Secondary | Number of Knees With Radiographic Failure Assessed Via the Knee Society Total Knee Arthroplasty Roentgenographic Score | Parameters for radiographic failures will follow the guidelines that have been set by the Knee Society. The scoring system for each of the three components is determined by measuring the width of the radiolucent lines for each of the zones in millimeters for each of the three components. The total widths in millimeters are added for each zone for each of the three prostheses. The total produces a numerical score for each component. Failure is defined as a score of 10 or greater, regardless of symptoms. | Participants/knees with available data. Overall number of participants and units analyzed is based upon the one year population. | Posted | Number | Total number of knees | 1, 2, and 5 years | knees | knees |
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| Secondary | Change in SF-36 Health Survey Over Time | 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 | preoperative, 1, 2, 3, 4, and 5 years | knees | knees |
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| Secondary | Change in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Over Time | The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes. | Participants/knees with available data. Data for the WOMAC is only available at the 2, 3, 4 and 5 year intervals in limited numbers due to typographical errors noted on earlier interval forms rendering them invalid for comparison. | Posted | Mean | Standard Deviation | units on a scale | preoperative,1, 2, 3, 4 and 5 years | knees | knees |
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| Secondary | Change in Lower-Extremity Activity Scale (LEAS) Over Time | 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 | preoperative, 1, 2, 3, 4, and 5 years | knees | knees |
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| Secondary | Patellar Subluxation, Dislocation and Fracture Rate | The incidence of patellar subluxation, dislocation or fracture is reported. | Participants/knees with available data at 5 years. | Posted | Count of Units | knees | 5 years | knees | knees |
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| Secondary | Patient Outcome Long Term Follow-up Questionnaire Over Time | Patient-reported outcome is collected using a long-term follow-up questionnaire at 6, 7, 8, 9, and 10 years postoperative for the subjects who consent to participation in the long-term follow-up study. The questionnaire consists of three yes or no questions:
| Participants/knees with available data. Overall number of participants and units analyzed is based upon the eight year postoperative population, as this was the largest available population between the 6-10 year postoperative intervals. | Posted | Count of Units | knees | 6, 7, 8, 9, and 10 years | knees | knees |
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| Secondary | Implant Survivorship | Implant survivorship at 10 years postoperative is determined using the Kaplan-Meier method. | Participants with available data. | Posted | Number | percentage of knees | 10 years | knees | knees |
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To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Years 6-10 operative-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion & mid-foot/flat-foot surgery.
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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-Site Adverse Events | Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Operative-site events are reported by knee. | 21 | 440 | 79 | 440 | ||
| EG001 | Systemic Adverse Events | Participants who received the Triathlon® CR Total Knee System and were not censored from analysis. Systemic events are reported by participant. | 90 | 411 | 0 | 411 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Systemic | Cardiac disorders | Non-systematic Assessment |
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| Systemic | Eye disorders | Non-systematic Assessment |
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| Systemic | Gastrointestinal disorders | Non-systematic Assessment |
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| Systemic | General disorders | Non-systematic Assessment |
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| Systemic | Infections and infestations | Non-systematic Assessment |
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| Systemic | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Operative-Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Systemic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Operative-Site | Nervous system disorders | Non-systematic Assessment |
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| Systemic | Psychiatric disorders | Non-systematic Assessment |
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| Systemic | Renal and urinary disorders | Non-systematic Assessment |
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| Systemic | Reproductive system and breast disorders | Non-systematic Assessment |
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| Operative-Site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Systemic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Operative-Site | Vascular disorders | Non-systematic Assessment |
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| Systemic | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Systemic | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Systemic | Nervous system disorders | Non-systematic Assessment |
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| Systemic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Systemic | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Each investigator shall have privileges for their own center's results at the completion of the study. These manuscripts and 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 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | Ellen.Axelson@Stryker.com |
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