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An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.
An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon CR Total Knee System | Other | Primary total knee replacement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon CR Total Knee System | Device | Primary total knee replacement |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Triathlon CR Active Range of Motion (ROM) | Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data. | 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of Patient Outcome With Radiographic Analysis | Plain radiographs will be obtained for assessment of fixation of the device. | Pre-operative, 3 months, 1, 2 and 5 years follow-up |
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Stukenborg-Colsman, Prof. | Medizinische Universität Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koge Sygehus | Køge | Roskilde | 4600 | Denmark | ||
| Hospital District of South West Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19047702 | Background | Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995. |
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The first patient included in the study was enrolled in October 2006. 168 cases received the Triathlon CR knee system over a 56 month period in a consecutive manner in 6 centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon CR Total Knee System | Primary total knee replacement Triathlon CR Total Knee System: Primary total knee replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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168 cases have received the Triathlon CR total knee replacement
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon CR Total Knee System | Progressive data: Primary total knee replacement |
| 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 |
| 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 | Mean Triathlon CR Active Range of Motion (ROM) | Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data. | Comparison to data from the literature was not done. | Posted | Mean | Standard Deviation | degree | 2 years follow-up |
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3 months, 1 year, 2 years, 5 years
Adverse event data were collected for the Triathlon CR arm during the follow-up visits.
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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 CR Total Knee System | Triathlon CR Primary total knee replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apoplex | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug McGurty | Stryker European Operations BV | +44(0)1635 500690 | doug.mcgurty@stryker.com |
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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. |
| Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
| Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
| Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 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. | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
| Turku |
| Westfinland |
| 20521 |
| Finland |
| DRK Klinik Baden-Baden | Baden-Baden | Baden-Wurttemberg | 76530 | Germany |
| Medizinische Universität Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Hospital Costa del Sol | Marbella | Andalusia | 24156005 W | Spain |
| Instituto Municipal de Asistencia Sanitaria | Barcelona | CP08003 | Spain |
| Exclusion criteria: Bilateral implant |
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| Missing data |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Range of Motion (ROM) | Mean | Standard Deviation | degree |
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| Participants |
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| Secondary | Investigation of Patient Outcome With Radiographic Analysis | Plain radiographs will be obtained for assessment of fixation of the device. | Radiographic data were not collected | Posted | Pre-operative, 3 months, 1, 2 and 5 years follow-up |
|
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| Secondary | Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (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. | The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | 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. | The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up |
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| 23 |
| 168 |
| 0 |
| 168 |
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Loosening of tibial component | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Contralateral knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Contralateral total knee replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hip Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Deep joint infection | Renal and urinary disorders | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Knee instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Knee pain, poor ROM | Vascular disorders | Non-systematic Assessment |
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| Multinodular goiter | Endocrine disorders | Non-systematic Assessment |
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| Patellar Subluxation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Poor ROM | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pulmonal infection | Infections and infestations | Non-systematic Assessment |
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| Soft tissue trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Flexion Contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| KSS Pain/Motion 1 year |
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| KSS Pain/Motion 2 years |
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| KSS Pain/Motion 5 years |
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