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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® Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio® PS implant.
The Triathlon® Posteriorly Stabilized (PS) 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® PS Total Knee System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon® PS Total Knee System | Other | Triathlon® PS Total Knee System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon® PS Total Knee System | Device | Triathlon® PS Total Knee system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion | The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Outcome Knee Society Score | The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. 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 |
|---|---|---|
| Eric R Benson, MD | New Hampshire Orthopaedic Surgery, PA | Principal Investigator |
| Daniel Moretta, DO | Tri County Orthopedics Surgeons, Inc. | Principal Investigator |
| James Bono, MD | New England Baptist Hospital | Principal Investigator |
| David W Edelstein, MD | Kelsey-Seybold Clinic | Principal Investigator |
| Philip Ireland, MD | Ireland Hip and Knee Surgery | Principal Investigator |
| Joseph P Nessler, MD | St. Cloud Orthopaedic Associates | Principal Investigator |
| Quanjun Cui, MD | University of Virginia | Principal Investigator |
| Arnold Scheller, MD | Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital | Principal Investigator |
| Joel Sorger, MD | Wellington Orthopaedics and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hughston Clinic PA | Columbus | Georgia | 31908 | United States | ||
| Ireland Hip and Knee Surgery |
409 participants/500 knees enrolled - 55 participants/65 knees censored = 354 participants/435 knees followed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon® PS Total Knee System | If both knees were replaced, but only one knee completed the study, the participant is counted as completed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 1,2 and 5 years |
| Patient Outcome SF-36 | The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state. | 1,2,3,4 and 5 years |
| Patient Outcome WOMAC | The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. 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. Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison. | 5 years |
| Patient Outcome Lower-Extremity Activity Scale | The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.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. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis. | 1,2,3,4 and 5 years |
| Radiographic Outcome | Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score. | 1,2 and 5 years |
| Suresh Nayak, MD |
| Wellington Orthopaedics and Sports Medicine |
| Principal Investigator |
| John I Waldrop, MD | Hughston Clinic, PA | Principal Investigator |
| James McGrory, MD | Hughston Clinic, PA | Principal Investigator |
| Steven B Zelicof, MD, PhD | Specialty Orthopaedics | Principal Investigator |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital | Boston | Massachusetts | 02445 | United States |
| St. Cloud Orthopaedic Associates | Sartell | Minnesota | 56377 | United States |
| New Hampshire Orthopaedic Surgery, PA | Manchester | New Hampshire | 03103 | United States |
| Specialty Orthopaedics | Harrison | New York | 10528 | United States |
| Wellington Orthopaedics & Sports Medicine | Cincinnati | Ohio | 45255 | United States |
| Tri County Orthopedic Surgeons, Inc. | Massillon | Ohio | 44646 | United States |
| Kelsey-Seybold Clinic | Houston | Texas | 77025 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Participants who were censored protocol violations or who were enrolled, but did not have surgery and age data was not available, are not included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon® PS Total Knee System | Participants who 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 | For bilateral total knee replacement participants, the age at the time of the initial knee replacement surgery is used. 3 participants did not have demographic data which would allow calculation of age; these participants did not receive the Triathlon® PS Total Knee System and are part of the "surgery cancelled" participant flow category. | Mean | Standard Deviation | years |
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| Gender | 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 | Range of Motion | The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System. | Participants can have both knees replaced. Range of motion is measured for each knee, as such the number of knees evaluated can be greater than the number of participants. | Posted | Mean | Standard Deviation | degrees | 2 years | Knees | Knees |
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| Secondary | Patient Outcome Knee Society Score | The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point. 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. | Maximum number of knees evaluated at any interval. | Posted | Mean | Standard Deviation | units on a scale | 1,2 and 5 years | knees | knees |
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| Secondary | Patient Outcome SF-36 | The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.The SF-36 includes a physical component and a mental component and is completed by the participant. Physical component and mental component scores were calculated on a scale ranging from 0 to 100. Low values represented a poor health state and high values represented a good health state. | Maximum number of knees evaluated at any interval. | Posted | Mean | Standard Deviation | units on a scale | 1,2,3,4 and 5 years | knees | knees |
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| Secondary | Patient Outcome WOMAC | The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point. 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. Data for the WOMAC is only available at the 5 year interval due to typographical errors noted on earlier interval forms rendering them invalid for comparison. | The number of knees evaluated at 5 years. | Posted | Mean | Standard Deviation | units on a scale | 5 years | knees | knees |
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| Secondary | Patient Outcome Lower-Extremity Activity Scale | The Lower-Extremity Activity Scale (LEAS) score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.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. A level of 1 indicated that the subject was confined to bed all day while a level of 18 indicated that the subject was up and about at will inside and outside of the house, and also participated in vigorous physical activity, such as competitive level sports, on a daily basis. | Maximum number of knees available at any interval. | Posted | Mean | Standard Deviation | units on a scale | 1,2,3,4 and 5 years | knees | knees |
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| Secondary | Radiographic Outcome | Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score. | Maximum number of knees evaluable at any interval. | Posted | Number | knees | 1,2 and 5 years | knees | knees |
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This study requires that all operative site and systemic adverse events be reported from enrollment to 5 years postoperative. This includes any change from baseline status. Censored protocol violations were not included as at risk participants.
Elective procedures are not included. These may include: non-study total knee/hip replacements/revisions, rotator cuff repairs, carpal tunnel releases, cataract & intra-ocular procedures, bunion procedures, total shoulder repairs, laminectomies, microdiscectomies, breast reductions, cervical spine fusions, & mid-foot/flat-foot surgeries.
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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 | Triathlon® PS Total Knee System | All non-censored participants who received the Triathlon® PS Total Knee System. | 86 | 354 | 194 | 354 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | Cardiac disorders | Non-systematic Assessment |
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| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
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| Non-operative Site | General disorders | Non-systematic Assessment |
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| Non-operative Site | Immune system disorders | Non-systematic Assessment |
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| Operative Site | Infections and infestations | Non-systematic Assessment |
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| Non-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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| Operative Site | Musculoskeletal and connective tissue 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 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Non-operative Site | Vascular disorders | Non-systematic Assessment |
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| Operative Site | Nervous system disorders | Non-systematic Assessment |
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| Non-operative Site | Ear and labyrinth disorders | Non-systematic Assessment |
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| Non-operative Site | Hepatobiliary 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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| Non-operative Site | Musculoskeletal and connective tissue 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 | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Non-operative Site | Gastrointestinal disorders | Non-systematic Assessment |
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| Non-operative Site | Nervous system 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 | Skin and subcutaneous 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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