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Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.
The goal of this study is to compare conventional UHMWPE with X3 highly cross-linked polyethylene in a CS fixed bearing total knee prosthesis (Triathlon Knee System: Stryker, Warsaw, USA) by means of RSA and clinical evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac) | Active Comparator | Conventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis |
|
| Highly cross-linked polyethylene (X3) | Active Comparator | X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon CS fixed bearing total knee prosthesis | Device | The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene. | 1, 2 and 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Prosthetic Migration Results After Two Years by RSA. | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components. |
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Inclusion Criteria:
Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
Patients with a pre-operative knee score of < 70.
Patients scheduled to undergo primary total knee replacement with any of the following indication.
Need to obtain pain relief and improve function.
Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
A good nutritional state of the patient.
Full skeletal maturity of the patient, patients who are at least 18 years of age.
Patients of either sex.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Kaptijn, MD | 't Langeland Ziekenhuis Zoetermeer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer | Zoetermeer | South Holland | 2725 NA | Netherlands |
Four patients were included into the study but not assigned to a group as prior to surgery two patients withdraw, one surgery was cancelled due to urinary tract infection and one patient met exclusion criteria BMI>40
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| ID | Title | Description |
|---|---|---|
| FG000 | N2Vac Polyethylene Inlay | Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
| FG001 | X3 Highly Cross-linked Polyethylene | X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Race or Ethnicity Baseline Measure is not captured in the Netherlands
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| ID | Title | Description |
|---|---|---|
| BG000 | N2Vac Polyethylene Inlay | Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
| BG001 | X3 Highly Cross-linked Polyethylene |
| 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 Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA). | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene. | Negative wear values represent a decrease in liner thickness (= wear). | Posted | Mean | Standard Deviation | mm | 1, 2 and 5 years follow-up |
|
Recording of Adverse Events ongoing from when the subject has signed the informed consent up to 5 years follow-up.
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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 | N2Vac Polyethylene Inlay | Conventional UHMWPE inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep infection operatve site | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britta von den Brincken, Clinical Study Manager | Stryker | +491638999202 | britta.vondenbrincken@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 | Jul 18, 2010 | Feb 21, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 13, 2011 | Feb 21, 2020 | ICF_001.pdf |
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| 3 and 6 months,1, 2 and 5 years follow-up |
| 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. | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
| Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (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. | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
| Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | The EuroQol-5 Dimension (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 visual analogue scale (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). | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
| Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | 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. | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
| Withdrawal by Subject |
|
| Adverse Event |
|
X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Indication | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| OG001 | X3 Highly Cross-linked Polyethylene | X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. |
|
|
| Secondary | Assessment of Prosthetic Migration Results After Two Years by RSA. | RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components. | The migration of the prosthesis components was calculated with a minimum of four RSA bone markers. In some cases only 3 RSA bone markers was used to calculate the migration, leading to inaccurate orientation matching of the bone markers. These patients are not included in the results describing the two different liner groups. | Posted | Mean | Standard Deviation | mm | 3 and 6 months,1, 2 and 5 years follow-up |
|
|
|
| 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. | Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (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. | Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire | The EuroQol-5 Dimension (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 visual analogue scale (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). | Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
|
|
|
| Secondary | Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire | 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. | Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years |
|
|
|
| 3 |
| 48 |
| 22 |
| 48 |
| 3 |
| 48 |
| EG001 | X3 Highly Cross-linked Polyethylene | X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis Triathlon CS fixed bearing total knee prosthesis: The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee. | 1 | 48 | 24 | 48 | 6 | 48 |
| Delayed wound healing operative site | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
|
| Flexion contracture operative site | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Hemarthrosis after use of anticoagulant | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
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| Arthrofibrosis operative site | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Instability operative site | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Bradicardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Hernia diafragmatica | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Gall bladder stones | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Diarrhea for 30 days | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Crohns Disease | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Collitis | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Infection of contralateral knee replacement | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
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| Face surgery after fall accident | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
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| Carpal Tunnel Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Carpometacarpal joint 1 resection | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Clavicle fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Shoulder tension rupture right | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Lumbar vertebra stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Tendovaginitis stenosis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Toxic thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Bowel cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Urothelial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
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| Delirium | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Stress incontinence | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Vascular sclerosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Inguinal artery obstruction | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Arteria femoralis occlusion both sides | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Vasovagal Collapse | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Stroke | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Deep vein thrombisis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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| Ex Smoker |
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| Femur migration 6 months |
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| Femur migration 1 year |
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| Femur migration 2 years |
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| Femur migration 5 years |
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| Tibia migration 3 months |
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| Tibia migration 6 months |
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| Tibia migration 1 year |
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| Tibia migration 2 years |
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| Tibia migration 5 years |
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| Pain motion score 6 weeks |
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| Pain motion score 3 months |
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| Pain motion score 6 months |
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| Pain motion score 1 year |
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| Pain motion score 2 years |
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| Pain motion score 5 years |
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| Function score pre-op |
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| Function score 6 weeks |
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| Function score 3 months |
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| Function score 6 months |
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| Function score 1 year |
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| Function score 2 years |
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| Function score 5 years |
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| Physical role functioning 6 weeks |
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| Physical role functioning 3 months |
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| Physical role functioning 6 months |
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| Physical role functioning 1 year |
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| Physical role functioning 2 years |
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| Physical role functioning 5 years |
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| Body pain pre-operative |
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| Body pain 6 weeks |
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| Body pain 3 months |
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| Body pain 6 months |
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| Body pain 1 year |
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| Body pain 2 years |
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| Body pain 5 years |
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| Vitality pre-operative |
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| Vitality 6 weeks |
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| Vitality 3 months |
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| Vitality 6 months |
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| Vitality 1 year |
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| Vitality 2 years |
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| Vitality 5 years |
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| Social role functioning pre-operative |
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| Social role functioning 6 weeks |
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| Social role functioning 3 months |
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| Social role functioning 6 months |
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| Social role functioning 1 year |
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| Social role functioning 2 years |
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| Social role functioning 5 years |
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| Emotional role functioning pre-operative |
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| Emotional role functioning 6 weeks |
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| Emotional role functioning 3 months |
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| Emotional role functioning 6 months |
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| Emotional role functioning 1 year |
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| Emotional role functioning 2 years |
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| Emotional role functioning 5 years |
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| Mental health pre-operative |
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| Mental health 6 weeks |
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| Mental health 3 months |
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| Mental health 6 months |
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| Mental health 1 year |
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| Mental health 2 years |
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| Mental health 5 years |
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| General health perceptions pre-op |
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| General health perceptions 6 weeks |
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| General health perceptions 3 months |
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| General health perceptions 6 months |
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| General health perceptions 1 year |
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| General health perceptions 2 years |
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| General health perceptions 5 years |
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| EQ-5D descriptive 6 weeks |
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| EQ-5D descriptive 3 months |
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| EQ-5D descriptive 6 months |
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| EQ-5D descriptive 1 year |
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| EQ-5D descriptive 2 years |
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| EQ-5D descriptive 5 years |
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| VAS pre-operative |
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| EQ-5D VAS 6 weeks |
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| EQ-5D VAS 3 months |
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| EQ-5D VAS 6 months |
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| EQ-5D VAS 1 year |
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| EQ-5D VAS 2 years |
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| EQ-5D VAS 5 years |
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| Activity level 6 weeks |
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| Activity level 3 months |
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| Activity level 6 months |
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| Activity level 1 year |
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| Activity level 2 years |
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| Activity level 5 years |
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