Trial Outcomes & Findings for An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery (NCT NCT01783483)

Last Updated: 2017-09-08

Results Overview

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 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular 2. \- 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 3. \- 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 4. \- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

Recruitment status

COMPLETED

Study phase

Target enrollment

236 participants

Primary outcome timeframe

3-month post-op

Results posted on

2017-09-08

Participant Flow

Subjects were considered eligible for enrollment if they were undergoing an open heart surgery (e.g. CABG and/or valve surgery) with a full median sternotomy and met the inclusion/exclusion criteria. Patients were randomized at the time of sternal closure to receive either rigid sternal fixation (using sternal plates) or standard wire cerclage.

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	120	116
Overall Study COMPLETED	100	101
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Death	3	3
Overall Study Lost to Follow-up	14	10
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	1	1

Baseline Characteristics

An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suture Wire n=120 Participants 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.	SternaLock Blu Sternal Closure System n=116 Participants 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	Total n=236 Participants Total of all reporting groups
Age, Continuous	65.7 Years STANDARD_DEVIATION 11.4 • n=5 Participants	65.3 Years STANDARD_DEVIATION 13.0 • n=7 Participants	65.5 Years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	86 Participants n=7 Participants	177 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Not Given	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
BMI	29.4 Kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	28.8 Kg/m^2 STANDARD_DEVIATION 4.7 • n=7 Participants	29.1 Kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants
Risk Factor [Diabetes]	44 Participants n=5 Participants	35 Participants n=7 Participants	79 Participants n=5 Participants
Risk Factor [Renal Failure]	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Risk Factor [Current Cigarette Smoker]	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Risk Factor [Hypertension]	83 Participants n=5 Participants	86 Participants n=7 Participants	169 Participants n=5 Participants
Risk Factor [Chronic Lung Disease] Mild	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Risk Factor [Chronic Lung Disease] Moderate	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Risk Factor [Chronic Lung Disease] Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Risk Factor [Chronic Lung Disease] None	98 Participants n=5 Participants	94 Participants n=7 Participants	192 Participants n=5 Participants
Risk Factor [Previous Sternotomy]	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Risk Factor [Ejection Fraction]	55.4 percentage STANDARD_DEVIATION 11.3 • n=5 Participants	55.2 percentage STANDARD_DEVIATION 11.9 • n=7 Participants	55.3 percentage STANDARD_DEVIATION 11.6 • n=5 Participants
Risk Factor [Congestive Heart Failure by NYHA Classification] Class I - No limitation of physical activity	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Risk Factor [Congestive Heart Failure by NYHA Classification] Class II - Slight limitation of physical activity	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Risk Factor [Congestive Heart Failure by NYHA Classification] Class III - Marked limitation of physical activity	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Risk Factor [Congestive Heart Failure by NYHA Classification] None (No heart failure present)	65 Participants n=5 Participants	70 Participants n=7 Participants	135 Participants n=5 Participants
Risk Factor [Peripheral Artery Disease]	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Risk Factor [Cerebral Vascular Disease]	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Risk Factor [Left Main Disease]	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Risk Factor [Previous Myocardial Infarction] More than 6h but less than 24h	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Risk Factor [Previous Myocardial Infarction] More than 1 day but less than 7 days	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Risk Factor [Previous Myocardial Infarction] More than 8 days but less than 21 days	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Risk Factor [Previous Myocardial Infarction] More than 21 days	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Risk Factor [Previous Myocardial Infarction] None or Never	100 Participants n=5 Participants	92 Participants n=7 Participants	192 Participants n=5 Participants
Inspirometry Volume	2436.3 mL STANDARD_DEVIATION 931.1 • n=5 Participants	2398.7 mL STANDARD_DEVIATION 1025.7 • n=7 Participants	2417.8 mL STANDARD_DEVIATION 976.8 • n=5 Participants

PRIMARY outcome

Timeframe: 3-month post-op

Population: Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu

Outcome measures

Outcome measures
Measure	Suture Wire n=102 Participants 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.	SternaLock Blu Closure System n=103 Participants 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
Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing	1.8 units on a scale Standard Deviation 1.0	2.6 units on a scale Standard Deviation 1.1

PRIMARY outcome

Timeframe: 6-month post-op

Population: Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu)

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 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular 2. \- 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 3. \- 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 4. \- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

Outcome measures

Outcome measures
Measure	Suture Wire n=100 Participants 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.	SternaLock Blu Closure System n=101 Participants 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
Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing	3.3 units on a scale 0-5 Standard Deviation 1.1	3.8 units on a scale 0-5 Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 7

Population: 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

Intensity of sternal pain assessed using 10 point scale: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

Outcome measures

Outcome measures
Measure	Suture Wire n=31 Participants 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.	SternaLock Blu Closure System n=30 Participants 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
Pain Measured in a 10-point Scale at Day 7 Post Operative At Rest	2.10 units on a scale 0-10 Standard Deviation 2.52	1.07 units on a scale 0-10 Standard Deviation 1.41
Pain Measured in a 10-point Scale at Day 7 Post Operative After Forced Coughing	4.23 units on a scale 0-10 Standard Deviation 2.64	2.20 units on a scale 0-10 Standard Deviation 2.06

SECONDARY outcome

Timeframe: 3-week Post-op

Population: 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

Intensity of sternal pain assessed using 10 point scale in the following circumstances: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

Outcome measures

Outcome measures
Measure	Suture Wire n=107 Participants 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.	SternaLock Blu Closure System n=107 Participants 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
Pain Measured in a 10-point Scale at 3-week Post Operative At Rest	1.04 units on a scale 0-10 Standard Deviation 1.57	0.79 units on a scale 0-10 Standard Deviation 1.37
Pain Measured in a 10-point Scale at 3-week Post Operative After Forced Coughing	2.99 units on a scale 0-10 Standard Deviation 2.56	1.92 units on a scale 0-10 Standard Deviation 2.30

SECONDARY outcome

Timeframe: 6-week Post-op

Population: 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

Outcome measures

Outcome measures
Measure	Suture Wire n=114 Participants 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.	SternaLock Blu Closure System n=112 Participants 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
Pain Measured in a 10-point Scale at 6-week Post Operative At Rest	1.14 units on a scale 0-10 Standard Deviation 1.91	0.54 units on a scale 0-10 Standard Deviation 1.15
Pain Measured in a 10-point Scale at 6-week Post Operative After Forced Coughing	1.90 units on a scale 0-10 Standard Deviation 2.19	1.26 units on a scale 0-10 Standard Deviation 1.88

SECONDARY outcome

Timeframe: 3-month Post-op

Population: 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

Outcome measures

Outcome measures
Measure	Suture Wire n=108 Participants 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.	SternaLock Blu Closure System n=105 Participants 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
Pain Measured in a 10-point Scale at 3-month Post Operative At Rest	0.46 units on a scale 0-10 Standard Deviation 1.03	0.39 units on a scale 0-10 Standard Deviation 1.38
Pain Measured in a 10-point Scale at 3-month Post Operative After Forced Coughing	1.01 units on a scale 0-10 Standard Deviation 1.73	0.74 units on a scale 0-10 Standard Deviation 1.49

SECONDARY outcome

Timeframe: 6-month Post-op

Population: 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

Outcome measures

Outcome measures
Measure	Suture Wire n=96 Participants 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.	SternaLock Blu Closure System n=102 Participants 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
Pain Measured in a 10-point Scale at 6-month Post Operative At Rest	0.65 units on a scale 0-10 Standard Deviation 1.38	0.55 units on a scale 0-10 Standard Deviation 1.43
Pain Measured in a 10-point Scale at 6-month Post Operative After Forced Coughing	0.76 units on a scale 0-10 Standard Deviation 1.56	0.54 units on a scale 0-10 Standard Deviation 1.26

SECONDARY outcome

Timeframe: Index (Day 0 to Hospital Discharge)

Population: Subjects with completed narcotic usage assessment from Day 0 to hospital discharge: 118 Suture Wire / 114 SternaLock Blu

Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).

Outcome measures

Outcome measures
Measure	Suture Wire n=118 Participants 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.	SternaLock Blu Closure System n=114 Participants 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
Narcotic Usage	72.75 milligrams of Morphine Equivalence Dose Standard Deviation 104.02	93.73 milligrams of Morphine Equivalence Dose Standard Deviation 227.28

SECONDARY outcome

Timeframe: From Hospital Discharge to 3-week post-op

Population: Subjects with completed narcotic usage assessment from hospital discharge to 3-week post op: 109 Suture Wire / 112 SternaLock Blu

Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .

Outcome measures

Outcome measures
Measure	Suture Wire n=109 Participants 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.	SternaLock Blu Closure System n=112 Participants 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
Narcotic Usage	33.04 milligrams of Morphine Equivalence Dose Standard Deviation 61.82	29.65 milligrams of Morphine Equivalence Dose Standard Deviation 110.28

SECONDARY outcome

Timeframe: From 3-week to 6-week post-op

Population: Subjects with completed narcotic usage assessment from 3-week to 6-week post op: 115 Suture Wire / 111 SternaLock Blu

Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .

Outcome measures

Outcome measures
Measure	Suture Wire n=115 Participants 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.	SternaLock Blu Closure System n=111 Participants 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
Narcotic Usage	9.65 milligrams of Morphine Equivalence Dose Standard Deviation 35.18	3.04 milligrams of Morphine Equivalence Dose Standard Deviation 9.92

SECONDARY outcome

Timeframe: From 6-week to 3-month post-op

Population: Subjects with completed narcotic usage assessment from 6-week to 3-month post op: 108 Suture Wire / 104 SternaLock Blu

Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .

Outcome measures

Outcome measures
Measure	Suture Wire n=108 Participants 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.	SternaLock Blu Closure System n=104 Participants 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
Narcotic Usage	17.11 milligrams of Morphine Equivalence Dose Standard Deviation 120.80	5.32 milligrams of Morphine Equivalence Dose Standard Deviation 25.08

SECONDARY outcome

Timeframe: From 3-month to 6 month post-op

Population: Subjects with completed narcotic usage assessment from 3-month to 6-month post op: 100 Suture Wire / 102 SternaLock Blu

Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .

Outcome measures

Outcome measures
Measure	Suture Wire n=100 Participants 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.	SternaLock Blu Closure System n=102 Participants 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
Narcotic Usage	48.32 milligrams of Morphine Equivalence Dose Standard Deviation 282.77	3.00 milligrams of Morphine Equivalence Dose Standard Deviation 12.72

Adverse Events

Suture Wire

Serious events: 10 serious events

Other events: 40 other events

Deaths: 3 deaths

SternaLock Blu Closure System

Serious events: 2 serious events

Other events: 37 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Suture Wire n=120 participants at risk 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.	SternaLock Blu Closure System n=116 participants at risk 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
Infections and infestations Deep Sternal Wound Infection (DSWI)	2.5% 3/120 • Number of events 8 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	0.00% 0/116 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%
Infections and infestations Superficial Sternal Wound Infection (SSWI)	1.7% 2/120 • Number of events 2 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	0.00% 0/116 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%
Surgical and medical procedures Other Sternal Wound Complication	0.83% 1/120 • Number of events 1 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	0.00% 0/116 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%
Cardiac disorders Bleeding requiring re-operation	1.7% 2/120 • Number of events 2 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	1.7% 2/116 • Number of events 2 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%
Nervous system disorders Stroke	0.83% 1/120 • Number of events 1 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	0.00% 0/116 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%
Renal and urinary disorders Acute Renal Failure	0.83% 1/120 • Number of events 1 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	0.00% 0/116 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%

Other adverse events

Other adverse events
Measure	Suture Wire n=120 participants at risk 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.	SternaLock Blu Closure System n=116 participants at risk 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
Cardiac disorders Arrythmia	33.3% 40/120 • Number of events 40 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%	31.9% 37/116 • Number of events 37 • From Day 0 to 6-month post op. Serious Adverse Events reporting sternal wound complications, deaths, bleeding requiring re-operations, stroke and acute renal failure per patient from Day 0 to 6-month post op. Other Adverse Events are reported if frequency of occurrence was higher than 5%

Additional Information

Brian M Hatcher, PhD

Zimmer Biomet

Phone: 904-741-4400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place