| Primary | Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome
- - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular
- - Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins
- - Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension
- - Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
| Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale | | 3-month post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
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| - OG0001.8± 1.0
- OG0012.6± 1.1
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Comparison of mean CT scan scores. | t-test, 2 sided | | <0.0001 | | | | | | | | | | | | | | Superiority or Other | | |
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| Primary | Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome
- - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular
- - Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins
- - Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension
- - Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
| Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu) | Posted | | Mean | Standard Deviation | units on a scale 0-5 | | 6-month post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. |
|
| Secondary | Pain Measured in a 10-point Scale at Day 7 Post Operative | Intensity of sternal pain assessed using 10 point scale:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
| Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain. Subjects at 7-Day post op with completed pain assessment: 31 Suture Wire / 30 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale 0-10 | | Day 7 | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Pain Measured in a 10-point Scale at 3-week Post Operative | Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
| Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain. Subjects at 3-week post op with completed pain assessment: 107 Suture Wire / 107 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale 0-10 | | 3-week Post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Pain Measured in a 10-point Scale at 6-week Post Operative | Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
| Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain. Subjects at 6-week post op with completed pain assessment: 114 Suture Wire / 112 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale 0-10 | | 6-week Post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Pain Measured in a 10-point Scale at 3-month Post Operative | Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
| Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain. Subjects at 3-month post op with completed pain assessment 108 Suture Wire / 105 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale 0-10 | | 3-month Post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Pain Measured in a 10-point Scale at 6-month Post Operative | Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
| Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain. Subjects at 6-month post op with completed pain assessment: 96 Suture Wire / 102 SternaLock Blu | Posted | | Mean | Standard Deviation | units on a scale 0-10 | | 6-month Post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED). | Subjects with completed narcotic usage assessment from Day 0 to hospital discharge: 118 Suture Wire / 114 SternaLock Blu | Posted | | Mean | Standard Deviation | milligrams of Morphine Equivalence Dose | | Index (Day 0 to Hospital Discharge) | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | Subjects with completed narcotic usage assessment from hospital discharge to 3-week post op: 109 Suture Wire / 112 SternaLock Blu | Posted | | Mean | Standard Deviation | milligrams of Morphine Equivalence Dose | | From Hospital Discharge to 3-week post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | Subjects with completed narcotic usage assessment from 3-week to 6-week post op: 115 Suture Wire / 111 SternaLock Blu | Posted | | Mean | Standard Deviation | milligrams of Morphine Equivalence Dose | | From 3-week to 6-week post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | Subjects with completed narcotic usage assessment from 6-week to 3-month post op: 108 Suture Wire / 104 SternaLock Blu | Posted | | Mean | Standard Deviation | milligrams of Morphine Equivalence Dose | | From 6-week to 3-month post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|
| Secondary | Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | Subjects with completed narcotic usage assessment from 3-month to 6-month post op: 100 Suture Wire / 102 SternaLock Blu | Posted | | Mean | Standard Deviation | milligrams of Morphine Equivalence Dose | | From 3-month to 6 month post-op | | | | ID | Title | Description |
|---|
| OG000 | Suture Wire | The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.). Suture Wire: Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy. | | OG001 | SternaLock Blu Closure System | Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body. SternaLock Blue closure system: SternaLock Blue closure system is a primary closure system plate-based |
|