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The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.
The evaluation is carried out by a prospective randomised RSA-study with Triathlon CR vs. Triathlon PS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon CR | Active Comparator | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. |
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| Triathlon PS | Active Comparator | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon CR | Device | Implantation of Knee Prosthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) | Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening. | 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score 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 |
|---|---|---|
| Sören Toksvig-Larsen, MD | Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skånevård Kryh Division Kirurgi och Ortopedkliniken Hässleholm | Hässleholm | Skåne County | 281 38 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon CR | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis |
| FG001 | Triathlon PS | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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With an alpha of 0.05 and a beta of 0.20 the required sample size in each group is 25 patients. Patients with inadequate marking will be excluded from the study. Taking the latter into account and to compensate for possible lost to follow up, 30 patients will be recruited per study group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon CR | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis |
| 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 | Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA) | Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening. | The number included in the analysis differs from the overall number analysed because that data were not collected. | Posted | Mean | Standard Deviation | mm | 2 years follow-up |
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During entire 10 years follow-up of all patients
All serious adverse events and operative site events occuring in this study were reported.
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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 | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon CR: Implantation of Knee Prosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Total knee replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Contralateral side |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Garling, PhD Snr. Director Medical & Scientific Affairs Europe | Stryker Orthopaedics | +31 6 467 135 18 | Eric.Garling@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 | Aug 29, 2007 | Feb 11, 2019 | Prot_SAP_000.pdf |
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| Triathlon PS |
| Device |
Implantation of Knee Prosthesis |
|
| pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome). | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | 1, 2, 5, 7 and 10 years |
| Investigation of Patient Outcome With Radiographic Analysis | Plain radiographs will be obtained for assessment of fixation of the device. | 3 months, 1, 2, 5, 7 and 10 years |
| Adverse Event |
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| Did not receive randomized study device |
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| BG001 | Triathlon PS | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ahlbäck Classification | According to Ahlbäck system, knee joint osteoarthritis is classified as: grade 1: joint space narrowing (less than 3 mm) grade 2: joint space obliteration grade 3: minor bone attrition (0-5 mm) grade 4: moderate bone attrition (5-10 mm) grade 5: severe bone attrition (more than 10 mm) | Count of Participants | Participants |
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| OG001 | Triathlon PS | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis |
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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: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score 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, 5, 7 and 10 years |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire | KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse 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, 5, 7 and 10 years |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire | The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health. With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | 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 | 1, 2, 5, 7 and 10 years |
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| Secondary | Investigation of Patient Outcome With Radiographic Analysis | Plain radiographs will be obtained for assessment of fixation of the device. | Plain radiographs were used for disease classification. Additional radiographs were not collected for the assessment of device fixation as the RSA analysis was used as an exact measurement of prosthesis components migration and implant fixation. | Posted | 3 months, 1, 2, 5, 7 and 10 years |
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| 4 |
| 28 |
| 3 |
| 28 |
| 0 |
| 28 |
| EG001 | Triathlon PS | Triathlon Cruciate Retaining (CR) versus Triathlon Posterior Stabilized (PS): During knee prosthesis surgery the surgeon many times need to make a judgement on if to keep a defect anatomical structure or if to replace it with knee prosthesis with a design that allows for adjustment of this defect. This study is aimed to evaluate which prosthetic choice to be made in respect of stability, long-term results and patient outcome. Triathlon PS: Implantation of Knee Prosthesis | 3 | 30 | 2 | 30 | 0 | 30 |
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| Pleomorphic Adenoma of Salivary Glands | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Uterine Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Uterine Cancer |
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| Epileptic fit | Nervous system disorders | Non-systematic Assessment |
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| Pressure Stroke | Vascular disorders | Non-systematic Assessment |
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