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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected.
It is hypothesized that X3 would perform equally well to N2Vac at 10 years.
This is a prospective, randomized and blinded clinical trial. Participants will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3, both FDA approved via 510k clearance) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. Specifically, the primary endpoint will be the revision rate at ten years. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. |
|
| Treatment | Experimental | Stryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X3 Polyethylene | Device | Highly cross-linked polyethylene (HXLPE). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prosthesis Survivorship Free of Revision | The survival of prostheses free of revision 10 years post operation. | From operation to 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthesis Survivorship Free of Reoperation | The survival of prostheses free of reoperation 10 years post operation. | From operation to 10 years post-operative |
| Prosthesis Survivorship Free of Complications |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Abdel, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic |
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Patients were recruited at the following sites: Mayo Clinic in Rochester, MN, Mayo Clinic in Florida, and Mayo Clinic in Arizona. Patients, who met study criteria, planning to undergo a total knee replacement were offered study participation at their pre-operative visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. N2Vac Polyethylene: Ultra-high-molecular-weight polyethylene (UHMWPE). |
| FG001 | Treatment | X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Stryker X3 Crosslink Polyethylene: Highly cross-linked polyethylene (HXLPE). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients were recruited from three academic, tertiary-care referral centers within one healthcare network. Patients approached for enrollment received a primary unilateral TKA for a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or posttraumatic arthritis. Patients were randomized into the control or treatment group. A Modified Intent-to-Treat (MITT) population was used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. N2Vac Polyethylene: Ultra-high-molecular-weight polyethylene (UHMWPE). |
| 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 | Prosthesis Survivorship Free of Revision | The survival of prostheses free of revision 10 years post operation. | Patients were recruited from three academic, tertiary-care referral centers within one healthcare network. Patients approached for enrollment received a primary unilateral total knee arthroplasty (TKA) for a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or posttraumatic arthritis. | Posted | Number | 95% Confidence Interval | percentage of prosthesis survivorship | From operation to 10 years post-operative |
|
Adverse events were monitored post-operatively day 1 until study completion (10 years).
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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 | Control | Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. N2Vac Polyethylene: Ultra-high-molecular-weight polyethylene (UHMWPE). |
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Wear related failures require significant lengths of time in which to present, longer-term data are necessary to definitively uncover differential wear and osteolysis risk between HXLPE and UHMWPE. The present investigation strictly utilized cemented femoral and tibial component fixation and posterior stabilized bearing designs. Additionally, 14% of patients were lost to follow-up by 10 years with the potential for bias therein; however, there was no differential attrition between groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emilee Andersen, M.A., Clinical Research Coordinator | Mayo Clinic, Rochester, MN | 507-266-9807 | andersen.emilee@mayo.edu |
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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 | Apr 29, 2013 | Aug 2, 2024 | Prot_SAP_000.pdf |
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| N2Vac Polyethylene | Device | Ultra-high-molecular-weight polyethylene (UHMWPE). |
|
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The survival of prostheses free of related complications (non-operative) 10 years post operation.
| From operation to 10 years post-operative |
| Knee Society Score (KSS) | The KSS evaluates pain, stability and range of motion. The scale ranges between scores of 0-100. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability. Deductions are made for flexion contracture, loss of extension and poor alignment. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions. | Pre-operative (baseline) and 10-years post-operative |
| Knee Society Score (KSS): Function | The Function KSS evaluates the walking distance and the act of climbing and descending stairs. The scale ranges between 0-100. The maximum score of 100 points is attributed to the individual capable of walking unlimited distances without walking aids, and of climbing and descending stairs normally. Deductions are made for the use of canes, crutches or walking frame. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions. | Pre-operative (baseline) and 10-years post-operative |
| 12-Item Short Form Health Survey (SF-12): Mental Health Score | The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health. | Pre-operative (baseline) and 10-years post-operative |
| 12-Item Short Form Health Survey (SF-12): Physical Health Score | The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health. | Pre-operative (baseline) and 10-years post-operative |
| Comparison of Radiographic Success/Failure Between Groups | Radiographic review for success and or failure of the TKA prostheses at 10 years post-operation. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is considered a failure. | 10 years post-operative |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Treatment |
X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Stryker X3 Crosslink Polyethylene: Highly cross-linked polyethylene (HXLPE). |
| 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 |
|
| Height (cm) | Mean | Standard Deviation | centimeters |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
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| BMI, kg/m^2 | Mean | Standard Deviation | Kilogram-Square Meter (kg/m^2) |
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| Previous knee surgery, n (%) | Count of Participants | Participants |
|
| OG001 | Treatment | Stryker Orthopaedics X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. X3 Crosslink Polyethylene: Highly cross-linked polyethylene (HXLPE). |
|
|
|
| Secondary | Prosthesis Survivorship Free of Reoperation | The survival of prostheses free of reoperation 10 years post operation. | Patients were recruited from three academic, tertiary-care referral centers within one healthcare network. Patients approached for enrollment received a primary unilateral total knee arthroplasty (TKA) for a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or posttraumatic arthritis. | Posted | Number | 95% Confidence Interval | percentage of prosthesis survivorship | From operation to 10 years post-operative |
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|
|
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| Secondary | Prosthesis Survivorship Free of Complications | The survival of prostheses free of related complications (non-operative) 10 years post operation. | Patients were recruited from three academic, tertiary-care referral centers within one healthcare network. Patients approached for enrollment received a primary unilateral total knee arthroplasty (TKA) for a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or posttraumatic arthritis. | Posted | Number | 95% Confidence Interval | percentage of prosthesis survivorship | From operation to 10 years post-operative |
|
|
|
|
| Secondary | Knee Society Score (KSS) | The KSS evaluates pain, stability and range of motion. The scale ranges between scores of 0-100. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability. Deductions are made for flexion contracture, loss of extension and poor alignment. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions. | Patients who completed the Knee Society Score at baseline and patients who completed the Knee Society Score at 10-years post-operation. Data was not collected nor analyzed for 90 patients in the control arm, and 93 patients in the treatment arm at the 10 year follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline) and 10-years post-operative |
|
|
|
| Secondary | Knee Society Score (KSS): Function | The Function KSS evaluates the walking distance and the act of climbing and descending stairs. The scale ranges between 0-100. The maximum score of 100 points is attributed to the individual capable of walking unlimited distances without walking aids, and of climbing and descending stairs normally. Deductions are made for the use of canes, crutches or walking frame. Higher scores indicate better knee conditions, while lower scores indicate worse knee conditions. | Patients who completed the Knee Society Function Score at baseline and patients who completed the Knee Society Function Score at 10-years post-operation. Data was not collected nor analyzed for 62 patients in the control arm, and 47 patients in the treatment arm at the 10 year follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline) and 10-years post-operative |
|
|
|
| Secondary | 12-Item Short Form Health Survey (SF-12): Mental Health Score | The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better mental health. | Patients who completed the SF-12 Mental Health Score at baseline and patients who completed the SF-12 Mental Health Score at 10-years post-operation. Data was not collected nor analyzed for 187 patients in the control arm, and 193 patients in the treatment arm at the 10 year follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline) and 10-years post-operative |
|
|
|
| Secondary | 12-Item Short Form Health Survey (SF-12): Physical Health Score | The SF-12 questionnaire uses questions selected from the longer SF-36 Health Survey to measure patient wellness and quality of life. The scoring algorithm is calibrated so that an average healthy person would have a t-score of 50 points with a standard deviation of 10. Higher scores indicate better physical health. | Patients who completed the SF-12 Physical Health Score at baseline and patients who completed the SF-12 Physical Health Score at 10-years post-operation. Data was not collected nor analyzed for 187 patients in the control arm, and 193 patients in the treatment arm at the 10 year follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline) and 10-years post-operative |
|
|
|
| Secondary | Comparison of Radiographic Success/Failure Between Groups | Radiographic review for success and or failure of the TKA prostheses at 10 years post-operation. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is considered a failure. | Patients who completed 10-year post-operation radiographs of the study-related prosthetic joint. | Posted | Count of Participants | Participants | 10 years post-operative |
|
|
|
| 55 |
| 254 |
| 0 |
| 254 |
| 0 |
| 254 |
| EG001 | Treatment | X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty. Stryker X3 Crosslink Polyethylene: Highly cross-linked polyethylene (HXLPE). | 50 | 264 | 0 | 264 | 0 | 264 |
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| Unknown |
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| 10-Year Follow-Up Score |
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| 10-Year Follow-Up Score |
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| 10-Year Follow-Up Score |
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| 10-Year Follow-Up Score |
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| Femoral component bone-prosthesis interface: Radiolucent lines |
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