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This study is a retrospective multicenter study to review the use of Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
This study is a retrospective investigation of subjects who have received primary Triathlon Total Knee Arthroplasty inserted with Simplex High Viscosity (HV) Cement to evaluate the success rate defined as absence of revision for aseptic loosening of components at two years postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-medicated Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. |
| |
| Gentamicin Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplex HV/Gentamicin Simplex HV bone cement | Device | Simplex HV bone cement is a fast-setting acrylic resin for use in bone surgery. Simplex HV bone cement with Gentamicin is a fast setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Application of Bone Cement | A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) Pain Motion Score: Range of Motion | The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg). | pre-op, 2 years, 5 years (optional) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all non-censored subjects who have received the Triathlon total knee system cemented with Simplex HV and are available for objective analysis.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Toms, Prof. | PEOC Royal Devon & Exeter Hospital | Principal Investigator |
| Matthew Hepinstall, MD | Department of Orthopedic Surgery NYU Langone Health | Principal Investigator |
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In the non-medicated Simplex HV group further three of the 97 subjects were excluded after enrollment as two subjects did not receive the study device and one subject met an exclusion criterion (Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days))
This was a retrospective study with planned 100 subjects per group. Recruitment was stopped in the Non-medicated Simplex HV group with 97 subjects because there were no additional eligible subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-medicated Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| FG001 | Gentamicin Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement. Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-medicated Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Participants With Successful Application of Bone Cement | A successful application is defined as absence of revision of Triathlon Total Knee components cemented with Simplex high viscosity bone cement (Simplex HV) within outcome measure timeframe. | Posted | Count of Participants | Participants | 24 months |
|
In this retrospective study adverse events were collected from time point of study related surgery up to 2 years.
No difference to ClinicalTrials.gov 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 | Non-medicated Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with nonmedicated Simplex HV Bone Cement. Simplex HV Bone Cement is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
The retrospective study approach did not allow for full KSS data collection. Data available were collected for analysis. In the retrospective data collection of this study, for some subjects were either no data or 2 years, respective 5 years data available. 5 years data are not mandatorily a consecutive follow-up of the 2 years data of the same subject. OKS was available for one site only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Britta von den Brincken | 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 | Jan 20, 2020 | Jan 26, 2024 | Prot_SAP_000.pdf |
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| KSS Pain Motion Score: Pain | This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects. | Pre-operative, 2 years, 5 years (optional) |
| KSS Function Score: Walking Aids | Pre- and postoperative use of walking aids | Pre-operative, 2 years, 5 years (optional) |
| KSS Function Score: Walking | Pre- and post-operative walking ability | pre-operative, 2 years, 5 years (optional) |
| KSS Function Score: Stairs | Pre-and postoperative ability of climbing stairs | Pre-operative, 2 years, 5 years (optional) |
| Oxford Knee Score (OKS) Results | The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function. | pre-op, 2 years, 5 years (optional) |
| KSS Pain Motion Score: Stability | This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability < 5 mm and medio-lateral (m/l) stability < 5° means mild increase in laxity compared to the contralateral knee. | pre-operative, 2 years, 5 years (optional) |
| BG001 | Gentamicin Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement. Simplex HV Bone Cement with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
| 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 | Count of Participants | Participants |
|
| Height cm | In the Simplex HV Gentamicin group, for some subjects height was not available in retrospective data collection. | Mean | Standard Deviation | centimeter |
|
| Weight kg | Mean | Standard Deviation | kilogram |
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| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Operative side | Count of Participants | Participants |
|
Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamicin Simplex HV Bone Cement. Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. |
|
|
| Secondary | Knee Society Score (KSS) Pain Motion Score: Range of Motion | The Knee range of motion (ROM) is a parameter which is calculating the range of knee extension (the ability to straighten the leg) and knee flexion (ability to bend the leg). A normal range is from 0º extension (completely straight leg) to 130º flexion (fully flexed leg). | The retrospective study approach did not allow for full KSS data collection. Range of motion data available were collected for analysis. | Posted | Mean | Standard Deviation | degrees | pre-op, 2 years, 5 years (optional) |
|
|
|
| Secondary | KSS Pain Motion Score: Pain | This section shows a five-level pain measurement from "no pain" to "severe pain" reported by the subjects. | The retrospective study approach did not allow for full KSS data collection. Pain data available were collected for analysis. | Posted | Count of Participants | Participants | Pre-operative, 2 years, 5 years (optional) |
|
|
|
| Secondary | KSS Function Score: Walking Aids | Pre- and postoperative use of walking aids | The retrospective study approach did not allow for full KSS data collection. Use of walking aids data available were collected for analysis. | Posted | Count of Participants | Participants | Pre-operative, 2 years, 5 years (optional) |
|
|
|
| Secondary | KSS Function Score: Walking | Pre- and post-operative walking ability | The retrospective study approach did not allow for full KSS data collection. Walking ability data available were collected for analysis. | Posted | Count of Participants | Participants | pre-operative, 2 years, 5 years (optional) |
|
|
|
| Secondary | KSS Function Score: Stairs | Pre-and postoperative ability of climbing stairs | The retrospective study approach did not allow for full KSS data collection. Stair climbing ability data available were collected for analysis of non-medicated Simplex HV only. | Posted | Count of Participants | Participants | Pre-operative, 2 years, 5 years (optional) |
|
|
|
| Secondary | Oxford Knee Score (OKS) Results | The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks. On a scale between 0 and 48, low values indicate severe knee problems and high values indicate satisfactory joint function. | Due to the retrospective study approach, the site of the Non-medicated Simplex HV arm did not collect OKS data and therefore OKS data cannot be presented for this site, whereas the site for the Gentamicin Simplex HV arm did collect OKS data which are presented. | Posted | Mean | Standard Deviation | score on a scale | pre-op, 2 years, 5 years (optional) |
|
|
|
| Secondary | KSS Pain Motion Score: Stability | This section shows number of patients with a minor knee ligament laxity. Antero-posterior (a/p) stability < 5 mm and medio-lateral (m/l) stability < 5° means mild increase in laxity compared to the contralateral knee. | The retrospective study approach in the Non-medicated Simplex HV study arm did not allow for full KSS Stability data collection as not all data were collected at 2 and 5 years. | Posted | Count of Participants | Participants | pre-operative, 2 years, 5 years (optional) |
|
|
|
| 0 |
| 95 |
| 10 |
| 95 |
| 18 |
| 95 |
| EG001 | Gentamicin Simplex HV | Retrospective observation of patients who have received a Triathlon Total Knee Replacement implanted with Gentamycin Simplex HV Bone Cement. Gentamicin Simplex HV Bone Cement is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. | 0 | 101 | 21 | 101 | 9 | 101 |
| Non-operative | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Non-operative | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
|
| Non-operative | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Non-operative | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Non-operative | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Non-operative | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
|
| Operative site | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
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| Operative site | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
|
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| 2 years ROM |
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| 5 years ROM |
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| Mild or occasional pain |
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| Moderate continual pain |
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| Moderate occasional pain |
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| Severe pain |
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| Pain at 2 years |
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| Pain at 5 years |
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| Crutches, Walker, cannot walk/ wheelchair Crutches, Walker, cannot walk, wheelchair |
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| Two canes, one crutch |
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| None |
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| Walking aids use at 2 years |
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| Walking aids use at 5 years |
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| Below 5 blocks (<500m/<1640 feet) |
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| 5-10 blocks (500m - 1000m/1640-3280 feet) |
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| Over 10 blocks (>1000m/>3280 feet) |
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| Unlimited |
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| Walking ability at 2 years |
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| Walking ability at 5 years |
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| Up with rail/unable down |
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| Up and down with rail |
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| Normal up/down with rail |
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| Normal up and down |
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| Ability to climb stairs at 2 years |
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| Ability to climb stairs at 5 years |
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| 2 years OKS |
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| 5 years OKS |
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| 2 years a/p <5mm and m/l <5° stability |
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| 5 years a/p <5mm and m/l <5° stability |
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