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Product discontinued in November 2014
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Randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria.
This study will be a prospective, randomized evaluation of the ShapeMatch Cutting Guide for primary total knee replacement (TKR) in a consecutive series of patients who meet the eligibility criteria. Forty-eight cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Another forty-eight cases enrolled will receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. And the last forty-eight cases will receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon® CR/Kinematic Alignment | Active Comparator | Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. |
|
| Triathlon® CR/Neutral Overall Limb Alignment | Active Comparator | Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. |
|
| Triathlon® CR/Conventional Limb Alignment | Active Comparator | Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon® CR/Kinematic Alignment | Device | Total knee replacement using patient-specific cutting guides |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy. | To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test | Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Catani, Prof. | Azienada Ospedaliero-Universitaria di Modena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany | ||
| Istituto Ortopedico Rizzoli |
12/56 patients received another procedure. Therefore 44 patients were enrolled in 4 centers.
56 patients have been screened for study participation. No patient withdrew his/her informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triathlon® CR/Kinematic Alignment | Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides |
| FG001 | Triathlon® CR/Neutral Overall Limb Alignment | Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides |
| FG002 | Triathlon® CR/Conventional Limb Alignment | Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Forty-four (44) patients were enrolled over an 11 month period in a randomized manner in 4 centers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triathlon® CR/Kinematic Alignment | Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy. | To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment. | Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group. | Posted | Mean | Standard Deviation | Degrees | 6 months |
|
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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/Kinematic Alignment | Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee. Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flexion deficit | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Garling, Director Medical & Scientific Affairs Europe | Stryker European Operations BV | +31 20 219 2660 | eric.garling@stryker.com |
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| Triathlon® CR/Neutral Overall Limb Alignment | Device | Total knee replacement using patient-specific cutting guides |
|
| Triathlon® CR/Conventional Limb Alignment | Device | Total knee replacement using traditional instrumentation |
|
| 1 year |
| 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 symptoms and 0 indicating extreme symptoms). | 1 year follow-up |
| Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire. | The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life. | 1 year follow-up |
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population. | 1 year follow-up |
| Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36). | The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | 1 year follow-up |
| Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With 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. | 1 year follow-up |
| Bologna |
| Emilia-Romagna |
| 40136 |
| Italy |
| Azienada Ospedaliero-Universitaria di Modena | Modena | 41124 | Italy |
| Royal Devon and Exeter NHS Foundation Trust | Exeter | Devon | EX2 5DW | United Kingdom |
| Triathlon® CR/Neutral Overall Limb Alignment |
Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides |
| BG002 | Triathlon® CR/Conventional Limb Alignment | Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.
Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides
| OG001 | Triathlon® CR/Neutral Overall Limb Alignment | Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides |
| OG002 | Triathlon® CR/Conventional Limb Alignment | Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation |
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test | Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls. | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | seconds | 1 year |
|
|
|
| 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 symptoms and 0 indicating extreme symptoms). | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year follow-up |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire. | The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life. | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year follow-up |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D). | The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population. | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year follow-up |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36). | The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year follow-up |
|
|
|
| Secondary | Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With 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. | Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis. | Posted | Mean | Standard Deviation | units on a scale | 1 year follow-up |
|
|
|
| 1 |
| 15 |
| 0 |
| 15 |
| EG001 | Triathlon® CR/Neutral Overall Limb Alignment | Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee. Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides | 4 | 11 | 0 | 11 |
| EG002 | Triathlon® CR/Conventional Limb Alignment | Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee. Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation | 2 | 18 | 0 | 18 |
| Instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Mammary Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Prostatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
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| Daily Living Activities |
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| Sport/Recreation |
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| Quality of Life |
|
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| Bodily Pain |
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| General Health |
|
| Vitality |
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| Social Functioning |
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| Role Emotional |
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| Mental Health |
|
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