An interventional study of Triathlon® PS Total Knee System in Arthroplasty, Replacement, Knee, sponsored by Stryker Orthopaedics. Completed at 11 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-25.
Sponsored by Stryker Orthopaedics · Not applicable, Interventional, and Treatment
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.
Stryker Orthopaedics is the lead sponsor of 44 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Triathlon® PS Total Knee System
Device: Triathlon® PS Total Knee System
Triathlon® PS Total Knee system
Range of Motion
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1,2 and 5 years
| Milestone | Triathlon® PS Total Knee System |
|---|---|
| Started | 354 |
| Completed | 237 |
| Not completed | 117 |
| Withdrew: Death | 5 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Withdrawal by subject | 34 |
| Withdrew: No 2 yr rom data | 35 |
| Withdrew: Revised study component by 2 yr visit | 8 |
| Withdrew: Site termination by the 2 yr visit | 16 |
| Withdrew: Surgery cancelled | 9 |
| Withdrew: Termination due to language issue | 2 |
The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.
| degrees | Triathlon® PS Total Knee System |
|---|---|
| Range of Motion | 124 ± 9.98 |
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.
| units on a scale | Triathlon® PS Total Knee System |
|---|---|
| Pain/Motion 1 Yr (N=335) | 93.77 ± 9.03 |
| Pain/Motion 1 Yr difference from Baseline (N=333) | 57.36 ± 16.80 |
| Function 1 Yr (N=340) | 86.26 ± 15.50 |
| Function 1 Yr difference from Baseline (N=340) | 30.99 ± 17.43 |
| Pain/Motion 2 Yr (N=281) | 93.96 ± 8.45 |
| Pain/Motion 2 Yr difference from Baseline (N=279) | 57.76 ± 17.20 |
| Function 2 Yr (N=284) | 87.38 ± 16.40 |
| Function 2 Yr difference from Baseline (N=284) | 32.55 ± 18.89 |
| Pain/Motion 5 Yr (N=230) | 94.61 ± 7.62 |
| Pain/Motion 5 Yr difference from Baseline (N=229) | 58.56 ± 16.35 |
| Function 5 Yr (N=232) | 82.07 ± 20.74 |
| Function 5 Yr difference from Baseline (N=232) | 27.33 ± 22.59 |
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.
| units on a scale | Triathlon® PS Total Knee System |
|---|---|
| SF36 Physical Component 1 Yr (N=335) | 48.16 ± 8.50 |
| SF36 Physical 1 Yr difference from Baseline(N=332) | 15.32 ± 9.28 |
| SF36 Mental Component 1 Yr (N=335) | 55.21 ± 8.02 |
| SF36 Mental 1Yr difference from Baseline(N=332) | 2.58 ± 11.06 |
| SF36 Physical Component 2Yr (N=290) | 47.34 ± 9.57 |
| SF36 Physical 2 Yr difference from Baseline(N=288) | 14.54 ± 9.75 |
| SF36 Mental Component 2 Yr (N=290) | 55.04 ± 8.10 |
| SF36 Mental 2Yr difference from Baseline(N=288) | 2.04 ± 10.90 |
| SF36 Physical Component 3Yr (N=259) | 47.23 ± 9.31 |
| SF36 Physical 3 Yr difference from Baseline(N=257) | 14.45 ± 9.58 |
| SF36 Mental Component 3 Yr (N=259) | 54.30 ± 9.68 |
| SF36 Mental 3 Yr difference from Baseline(N=257) | 1.93 ± 11.06 |
| SF36 Physical Component 4 Yr (N=254) | 46.26 ± 10.05 |
| SF36 Physical 4 Yr difference from Baseline(N=253) | 13.58 ± 10.54 |
| SF36 Mental Component 4 Yr (N=254) | 54.49 ± 8.74 |
| SF36 Mental 4 Yr difference from Baseline(N=253) | 1.93 ± 10.88 |
| SF36 Physical Component 5 Yr (N=243) | 46.33 ± 9.72 |
| SF36 Physical 5 Yr difference from Baseline(N=242) | 13.65 ± 10.82 |
| SF36 Mental Component 5 Yr (N=243) | 54.82 ± 7.97 |
| SF36 Mental 5 Yr difference from Baseline(N=242) | 2.25 ± 11.06 |
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.
| units on a scale | Triathlon® PS Total Knee System |
|---|---|
| Patient Outcome WOMAC | 45.11 ± 53.96 |
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.
| units on a scale | Triathlon® PS Total Knee System |
|---|---|
| LEAS 1 Year (N=339) | 11.22 ± 2.62 |
| LEAS 1 Year difference from Baseline (N=339) | 1.97 ± 2.84 |
| LEAS 2 Year (N=291) | 11.04 ± 2.63 |
| LEAS 2 Year difference from Baseline (N=291) | 1.86 ± 2.98 |
| LEAS 3 Year (N=266) | 11.15 ± 2.87 |
| LEAS 3 Year difference from Baseline (N=266) | 1.95 ± 3.12 |
| LEAS 4 Year (N=262) | 10.97 ± 2.76 |
| LEAS 4 Year difference from Baseline (N=262) | 1.87 ± 3.03 |
| LEAS 5 Year (N=244) | 11.02 ± 2.93 |
| LEAS 5 Year difference from Baseline (N=244) | 1.89 ± 3.14 |
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.
| knees | Triathlon® PS Total Knee System |
|---|---|
| Radiographic failure at 1 Yr (N=347 knees) | 1 |
| Radiographic failure at 2 Yrs (N=282 knees) | 2 |
| Radiographic failure at 5 Yrs (N=217 knees) | 3 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triathlon® PS Total Knee System | — | 86/354 (24.3%) | 194/354 (54.8%) |
| Event | Triathlon® PS Total Knee System |
|---|---|
| Operative SiteMusculoskeletal and connective tissue disorders | 21/354 |
| Non-operative SiteMusculoskeletal and connective tissue disorders | 16/354 |
| Non-operative siteCardiac disorders | 15/354 |
| Non-operative SiteRespiratory, thoracic and mediastinal disorders | 12/354 |
| Non-operative siteGastrointestinal disorders | 9/354 |
| Non-operative SiteNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 9/354 |
| Operative SiteInfections and infestations | 8/354 |
| Non-operative SiteNervous system disorders | 4/354 |
| Non-operative SiteInfections and infestations | 3/354 |
| Non-operative SiteRenal and urinary disorders | 3/354 |
| Event | Triathlon® PS Total Knee System |
|---|---|
| Non-operative SiteMusculoskeletal and connective tissue disorders | 111/354 |
| Operative SiteMusculoskeletal and connective tissue disorders | 90/354 |
| Non-operative SiteBlood and lymphatic system disorders | 31/354 |
| Non-operative SiteRespiratory, thoracic and mediastinal disorders | 29/354 |
| Non-operative SiteGastrointestinal disorders | 27/354 |
| Non-operative SiteSkin and subcutaneous tissue disorders | 26/354 |
| Non-operative SiteNervous system disorders | 24/354 |
| Non-operative SiteRenal and urinary disorders | 22/354 |
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.
| Age, Continuous(years) | Triathlon® PS Total Knee System |
|---|---|
| Mean | 65.12 ± 8.59 |
| Gender(Participants) | Triathlon® PS Total Knee System |
|---|---|
| Female | 200 |
| Male | 151 |
| Region of Enrollment(participants) | Triathlon® PS Total Knee System |
|---|---|
| United States | 351 |
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stryker Orthopaedics