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The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VITAMIN E | Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing |
| |
| POLYETHYLENE | Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GKS Prime Flex Mobile knee | Device | Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival for Aseptic Loosening | Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point | 10-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival for Any Reason | Kaplan-Meier cumulative survival with revision due to any reason as the end-point | 10-year follow-up |
| Forgotten Joint Score (FJS-12) | Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing
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| Name | Affiliation | Role |
|---|---|---|
| Marco Spezia, MD | Ospedale Centro Ortopedico di Quadrante | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Centro Ortopedico di Quadrante | Omegna | Verbania | 28887 | Italy |
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186 participants (199 knees) were enrolled in the study and were assigned to each arm
During recruitment process, 350 total knee arthroplasties (181 with vitamin E polyethylene and 169 with conventional polyethylene) were identified as eligible. Overall 151 total knee arthroplasties were lost to follow-up and were not enrolled (79 with vitamin E polyethylene and 72 with conventional polyethylene). 186 participants (199 knees) were enrolled.
| ID | Title | Description |
|---|---|---|
| FG000 | VITAMIN E | Cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing and GKS Prime Flex Mobile knee |
| FG001 | POLYETHYLENE | Cemented total knee arthroplasty with conventional polyethylene mobile bearing and GKS Prime Flex Mobile knee |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis Population included overall number of implants (knees) without those implants lost to follow-up. Patients deceased of causes unrelated to their implant with no history of implant revision, as documented by medical records and by telephone contact with their family, will be included and considered as censored events in survival analysis
| ID | Title | Description |
|---|---|---|
| BG000 | VITAMIN E | Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing GKS Prime Flex Mobile knee: Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis |
| BG001 | 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 | Implant Survival for Aseptic Loosening | Kaplan-Meier cumulative survival with revision due to aseptic loosening as the end-point | Posted | Number | 95% Confidence Interval | percentage of survival implants | 10-year follow-up | Knees (knee implants) | Knees (knee implants) |
|
At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively
Surgical implant revision with prosthetic component replacement and surgical reintervention fall within the Serious adverse events definition
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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 | VITAMIN E | Patients who received cemented total knee arthroplasty with vitamin E blended polyethylene mobile bearing GKS Prime Flex Mobile knee: Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision for aseptic loosening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Higher than expected number of knees lost to follow-up. Non homogeneous groups for age, gender, and BMI, which might have biased results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Banci, study coordinator - clinical affairs | Permedicaspa | 0399514811 | lorenzo.banci@permedica.it |
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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 | Sep 18, 2020 | Jul 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively |
| American Knee Society Score (KSS) | Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes) | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively |
| Periprosthetic Radiolucent Line | Radiographic sign of bone remodelling around the implant | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively |
| Periprosthetic Osteolysis | Radiographic sign of focal bone resorption around the implant | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively |
Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing GKS Prime Flex Mobile knee: Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis |
| BG002 | Total | Total of all reporting groups |
| Knees (Knee implants) |
|
| years |
| Knees (Knee implants) |
|
|
| Sex: Female, Male | Count of Units | Knees (Knee implants) | Knees (Knee implants) |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Follow-up | Mean | Standard Deviation | years | Knees (Knee implants) |
|
|
| Diagnosis | Count of Units | Knees (Knee implants) | Knees (Knee implants) |
|
|
| BMI | Mean | Standard Deviation | kg/m^2 | Knees (Knee implants) |
|
|
|
|
| Secondary | Implant Survival for Any Reason | Kaplan-Meier cumulative survival with revision due to any reason as the end-point | Posted | Number | 95% Confidence Interval | percentage of survival implants | 10-year follow-up | Knees (knee implants) | Knees (knee implants) |
|
|
|
| Secondary | Forgotten Joint Score (FJS-12) | Patient related outcome measurement scored from 0 to 100 (higher scores mean better outcomes) | Number of knees of patients who was contacted by phone or who returned back to hospital for clinical examination follow-up | Posted | Mean | Standard Deviation | score on a scale | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively | Knees (knee implants) | Knees (knee implants) |
|
|
|
| Secondary | American Knee Society Score (KSS) | Clinical and Functional scores of the knee. Both scores are scored from 0 to 100 (higher scores mean better outcomes) | Knees of patients who returned back to the hospital for complete clinical and radiographic follow-up | Posted | Mean | Standard Deviation | score on a scale | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively | Knees (knee implants) | Knees (knee implants) |
|
|
|
| Secondary | Periprosthetic Radiolucent Line | Radiographic sign of bone remodelling around the implant | Knees of patients who returned back to hospital for clinical and radiographic follow-up. | Posted | Count of Units | Knees (knee implants) | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively | Knees (knee implants) | Knees (knee implants) |
|
|
|
| Secondary | Periprosthetic Osteolysis | Radiographic sign of focal bone resorption around the implant | Knees of patients who returned back to hospital for clinical and radiographic follow-up | Posted | Count of Units | Knees (knee implants) | At mean follow-up of 8.5 years and 8.3 years for Vitamin E and Polyethylene, respectively | Knees (knee implants) | Knees (knee implants) |
|
|
|
| 4 |
| 102 |
| 18 |
| 102 |
| 22 |
| 102 |
| EG001 | POLYETHYLENE | Patients who received cemented total knee arthroplasty with conventional polyethylene mobile bearing GKS Prime Flex Mobile knee: Total knee arthroplasty with a cemented mobile bearing bicompartmental knee prosthesis | 21 | 97 | 16 | 97 | 14 | 97 |
| Revision for any reason other than aseptic loosening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Reintervention for patella resurfacing | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Reintervention for other reason than patella resurfacing | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Deep venous thrombosis | Cardiac disorders | Systematic Assessment |
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| Ventricular tachycardis | Cardiac disorders | Systematic Assessment |
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| Painfull knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Intraoperative bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Delayed wound healing | Infections and infestations | Systematic Assessment |
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| Instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| Post-traumatic osteoarthritis |
|