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| ID | Type | Description | Link |
|---|---|---|---|
| K-S-015_1 | Other Identifier | StrykerEuropean |
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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 evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented knee prosthesis versus Duracon cemented knee prosthesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cemented Triathlon total knee system | Active Comparator | The Triathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study. |
|
| Cemented Duracon total knee system | Active Comparator | The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented Triathlon total knee system | Device | Orthopaedic implant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Roentgen Stereophotogrammetric Analysis (RSA) | To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Roentgen Stereophotogrammetric Analysis (RSA) | To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA. | 3 months, 1, 5, 7 and 10 years |
| Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sören Toksvig-Larsen, ass. prof | Department of ortopaedics, Hässleholm Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hässleholm Hospital | Hässleholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23610663 | Result | Molt M, Ljung P, Toksvig-Larsen S. Does a new knee design perform as well as the design it replaces? Bone Joint Res. 2012 Dec 1;1(12):315-23. doi: 10.1302/2046-3758.112.2000064. Print 2012 Dec. | |
| 24974301 | Derived | Molt M, Toksvig-Larsen S. Similar early migration when comparing CR and PS in Triathlon TKA: A prospective randomised RSA trial. Knee. 2014 Oct;21(5):949-54. doi: 10.1016/j.knee.2014.05.012. Epub 2014 Jun 7. |
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The recruitment period was from February to November 2006. In a single centre patients were prospectively randomised to receive either a cemented Triathlon total knee system or a Duracon total knee system. Randomisation with envelopes, 30 patients in each group. Only one knee per participant was enrolled for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cemented Triathlon Total Knee System | 30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study. Cemented Triathlon total knee system: Orthopaedic implant |
| FG001 | Duracon Total Knee System | 30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study. Duracon total knee system: Orthopaedic implant |
| 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 to detect a difference of 0.3 mm. 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 | 30 patients randomized into the Triathlon arm |
| BG001 | Duracon | 30 patients randomized into the Duracon arm |
| 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 | Roentgen Stereophotogrammetric Analysis (RSA) | To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components at two years assessed by means of RSA. | Posted | Mean | Standard Deviation | mm | 2 years |
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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 | 30 patients randomized into the Triathlon arm |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Garling, PhD, Snr. Director Medical & Scientific Affairs Europe | Stryker EU Operations B.V. Herikerbergweg 110 1101 CM Amsterdam The Netherlands | +31 20 219 2660 | Eric.Garling@stryker.com |
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| Duracon total knee system |
| Device |
Orthopaedic implant |
|
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: pre-operative, 3 months, 1, 2, 5, 7 and 10 years] |
| Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire | KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) 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 symptoms and 0 indicating extreme symptoms) is calculated for each subscale. [taken from User Guide] http://www.koos.nu/ | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Investigation of Clinical Performance and Patient Outcome With 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; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected. | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
| Mean Operative Time | Skin to skin operative time | intra-operative |
| Duration Hospital Stay | preoperative to discharge |
| Blood Loss | Blood loss during surgery | intra-operative |
| no RSA data |
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| BG002 | Total | Total of all reporting groups |
| 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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| Participants |
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| Secondary | Roentgen Stereophotogrammetric Analysis (RSA) | To compare the maximum total point motion (MTPM) of the Triathlon and Duracon tibial components by means of RSA. | Participants with data available at each time point. | Posted | Mean | Standard Deviation | mm | 3 months, 1, 5, 7 and 10 years |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With KSS (Knee Society Score) | 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 with data available at each time point. | Posted | Mean | Standard Deviation | units on a scale | [Time Frame: pre-operative, 3 months, 1, 2, 5, 7 and 10 years] |
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| Secondary | Investigation of Clinical Performance and Patient Outcome With KOOS Patient Questionnaire | KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) 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 symptoms and 0 indicating extreme symptoms) is calculated for each subscale. [taken from User Guide] http://www.koos.nu/ | Participants with data available at each time point. | 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 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; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health. NOTE: While the protocol includes pre-operative, 3 months, and 1 year, this data was not collected. | Participants with data available at each time point. Overall number of participants and units analyzed is based upon the 2 year population | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 3 months, 1, 2, 5, 7 and 10 years |
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| Secondary | Mean Operative Time | Skin to skin operative time | Posted | Mean | Standard Deviation | minutes | intra-operative |
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| Secondary | Duration Hospital Stay | Posted | Mean | Standard Deviation | days | preoperative to discharge |
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| Secondary | Blood Loss | Blood loss during surgery | The protocol indicates blood loss as a secondary measure but this value was not collected. Therefore no data can be posted. | Posted | intra-operative |
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| 4 |
| 30 |
| 4 |
| 30 |
| EG001 | Duracon | 30 patients randomized into the Duracon arm | 3 | 30 | 5 | 30 |
| Fracture proximal tibia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hip fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Supercondylar humerus fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Atrioventricular block | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| MTPM 1 year |
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| MTPM 5 years |
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| MTPM 7 years |
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| MTPM 10 years |
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| KSS Pain/Motion 3 months |
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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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| KSS Pain/Motion 7 years |
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| KSS Pain/Motion 10 years |
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| KSS Function pre-operative |
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| KSS Function 3 months |
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| KSS Function 1 year |
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| KSS Function 2 years |
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| KSS Function 5 years |
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| KSS Function 7 years |
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| KSS Function 10 years |
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| QOL 3 months |
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| QOL 1 year |
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| QOL 2 years |
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| QOL 5 years |
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| QOL 7 years |
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| QOL 10 years |
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| Symptoms preoperative |
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| Symptoms 3 months |
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| Symptoms 1 year |
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| Symptoms 2 years |
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| Symptoms 5 years |
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| Symptoms 7 years |
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| Symptoms 10 years |
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| Pain preoperative |
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| Pain 3 months |
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| Pain 1 year |
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| Pain 2 years |
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| Pain 5 years |
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| Pain 7 years |
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| Pain 10 years |
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| ADL preoperative |
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| ADL 3 months |
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| ADL 1 year |
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| ADL 2 years |
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| ADL 5 years |
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| ADL 7 years |
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| ADL 10 years |
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| Sport/Rec preOP |
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| Sport/Rec 3 months |
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| Sport/Rec 1 year |
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| Sport/Rec 2 years |
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| Sport/Rec 5 years |
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| Sport/Rec 7 years |
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| Sport/Rec 10 years |
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| EQ-5D 5 years |
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| EQ-5D 7 years |
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| EQ-5D 10 years |
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