Angina Pectoris, Cardiac Valve Disease, Coronary Artery Disease
Conditions
Keywords
CABG, Valve replacement, sternal closure, midline sternotomy, sternal plates
Brief summary
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.
Detailed description
Rigid sternal fixation with the BIOMET SternaLock Blu Sternal Closure System may result in greater sternal stability that leads to superior sternal bone healing, less postoperative pain and narcotic usage, and improved functional outcomes compared to wire cerclage. The health economics analysis is an interesting component of this study, in which cost and billing data will be collected from participating sites and analyzed in terms of cost/effectiveness for patients and healthcare system.
Interventions
DEVICESternaLock Blue closure system
SternaLock Blue closure system is a primary closure system plate-based
DEVICESuture Wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a full standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures) * Patients admitted to the hospital the day of or the day before their scheduled surgical procedure * Patients ≥ 18 years of age * Patients with a BMI \< 40
Exclusion criteria
Pre-operative * Patients with endstage renal failure who are on dialysis * Patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 \< 50% or patients on on-home oxygen) * Patients on prescribed pre-operative narcotics * Patients taking chronic steroids, biologics acting as immunosuppressants (e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), or chemotherapeutics (iv or oral chemotherapeutics for cancer). Patients using a steroid inhaler for asthma should not be excluded. * Patients with an active infection as defined by a positive culture * Patients with foreign body sensitivity * Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions * Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA) * Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS) * Patients unwilling or unable to return for follow-up Operative * Patients requiring delayed sternotomy closure * Patients with an off-midline sternotomy reducing the bony margin between a SternaLock screw body and an osteotomy to within 2mm or less * Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude the use of either wire cerclage or rigid fixation, or who are not able to be plated or wired per the protocol (e.g. patients who in the opinion of the surgeon have insufficient quantity of quality of sternal bone; redo sternotomy with excessive fibrous tissue) * Use of non resorbable (beeswax) bonewax * Intraoperative death prior to device placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 3-month post-op | 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 |
| Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 6-month post-op | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured in a 10-point Scale at 6-week Post Operative | 6-week Post-op | 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 |
| Pain Measured in a 10-point Scale at 3-month Post Operative | 3-month Post-op | 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 |
| Pain Measured in a 10-point Scale at Day 7 Post Operative | Day 7 | 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 |
| Narcotic Usage | Index (Day 0 to Hospital Discharge) | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED). |
| Pain Measured in a 10-point Scale at 6-month Post Operative | 6-month Post-op | 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 |
| Pain Measured in a 10-point Scale at 3-week Post Operative | 3-week Post-op | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 120 |
| SternaLock Blu Sternal 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 | 116 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 3 |
| Overall Study | Lost to Follow-up | 14 | 10 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | SternaLock Blu Sternal Closure System | Suture Wire | Total |
|---|---|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 13 | 65.7 Years STANDARD_DEVIATION 11.4 | 65.5 Years STANDARD_DEVIATION 12.2 |
| BMI | 28.8 Kg/m^2 STANDARD_DEVIATION 4.7 | 29.4 Kg/m^2 STANDARD_DEVIATION 4.6 | 29.1 Kg/m^2 STANDARD_DEVIATION 4.7 |
| Inspirometry Volume | 2398.7 mL STANDARD_DEVIATION 1025.7 | 2436.3 mL STANDARD_DEVIATION 931.1 | 2417.8 mL STANDARD_DEVIATION 976.8 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 7 Participants | 12 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Not Given | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 103 Participants | 102 Participants | 205 Participants |
| Risk Factor [Cerebral Vascular Disease] | 10 Participants | 7 Participants | 17 Participants |
| Risk Factor [Chronic Lung Disease] Mild | 18 Participants | 15 Participants | 33 Participants |
| Risk Factor [Chronic Lung Disease] Moderate | 4 Participants | 7 Participants | 11 Participants |
| Risk Factor [Chronic Lung Disease] None | 94 Participants | 98 Participants | 192 Participants |
| Risk Factor [Chronic Lung Disease] Severe | 0 Participants | 0 Participants | 0 Participants |
| Risk Factor [Congestive Heart Failure by NYHA Classification] Class III - Marked limitation of physical activity | 15 Participants | 11 Participants | 26 Participants |
| Risk Factor [Congestive Heart Failure by NYHA Classification] Class II - Slight limitation of physical activity | 21 Participants | 27 Participants | 48 Participants |
| Risk Factor [Congestive Heart Failure by NYHA Classification] Class I - No limitation of physical activity | 10 Participants | 17 Participants | 27 Participants |
| Risk Factor [Congestive Heart Failure by NYHA Classification] None (No heart failure present) | 70 Participants | 65 Participants | 135 Participants |
| Risk Factor [Current Cigarette Smoker] | 14 Participants | 10 Participants | 24 Participants |
| Risk Factor [Diabetes] | 35 Participants | 44 Participants | 79 Participants |
| Risk Factor [Ejection Fraction] | 55.2 percentage STANDARD_DEVIATION 11.9 | 55.4 percentage STANDARD_DEVIATION 11.3 | 55.3 percentage STANDARD_DEVIATION 11.6 |
| Risk Factor [Hypertension] | 86 Participants | 83 Participants | 169 Participants |
| Risk Factor [Left Main Disease] | 26 Participants | 24 Participants | 50 Participants |
| Risk Factor [Peripheral Artery Disease] | 12 Participants | 5 Participants | 17 Participants |
| Risk Factor [Previous Myocardial Infarction] More than 1 day but less than 7 days | 4 Participants | 2 Participants | 6 Participants |
| Risk Factor [Previous Myocardial Infarction] More than 21 days | 1 Participants | 0 Participants | 1 Participants |
| Risk Factor [Previous Myocardial Infarction] More than 6h but less than 24h | 3 Participants | 0 Participants | 3 Participants |
| Risk Factor [Previous Myocardial Infarction] More than 8 days but less than 21 days | 16 Participants | 18 Participants | 34 Participants |
| Risk Factor [Previous Myocardial Infarction] None or Never | 92 Participants | 100 Participants | 192 Participants |
| Risk Factor [Previous Sternotomy] | 8 Participants | 5 Participants | 13 Participants |
| Risk Factor [Renal Failure] | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 30 Participants | 29 Participants | 59 Participants |
| Sex: Female, Male Male | 86 Participants | 91 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 120 | 2 / 116 |
| other Total, other adverse events | 40 / 120 | 37 / 116 |
| serious Total, serious adverse events | 10 / 120 | 2 / 116 |
Outcome results
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 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
Time frame: 3-month post-op
Population: Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | 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 |
| SternaLock Blu Closure System | Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 2.6 units on a scale | Standard Deviation 1.1 |
Comparison: Comparison of mean CT scan scores.p-value: <0.0001t-test, 2 sided
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 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
Time frame: 6-month post-op
Population: Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | 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 |
| SternaLock Blu Closure System | Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 3.8 units on a scale 0-5 | Standard Deviation 1 |
p-value: 0.0007t-test, 2 sided
Secondary
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | Narcotic Usage | 33.04 milligrams of Morphine Equivalence Dose | Standard Deviation 61.82 |
| SternaLock Blu Closure System | Narcotic Usage | 29.65 milligrams of Morphine Equivalence Dose | Standard Deviation 110.28 |
Comparison: From Hospital Discharge to 3-weekp-value: 0.778t-test, 2 sided
Secondary
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | Narcotic Usage | 9.65 milligrams of Morphine Equivalence Dose | Standard Deviation 35.18 |
| SternaLock Blu Closure System | Narcotic Usage | 3.04 milligrams of Morphine Equivalence Dose | Standard Deviation 9.92 |
Comparison: From 3-week to 6-week post-opp-value: 0.055t-test, 2 sided
Secondary
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | Narcotic Usage | 72.75 milligrams of Morphine Equivalence Dose | Standard Deviation 104.02 |
| SternaLock Blu Closure System | Narcotic Usage | 93.73 milligrams of Morphine Equivalence Dose | Standard Deviation 227.28 |
Comparison: Index (Day 0 to Hospital Discharge)p-value: 0.37t-test, 2 sided
Secondary
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | Narcotic Usage | 17.11 milligrams of Morphine Equivalence Dose | Standard Deviation 120.8 |
| SternaLock Blu Closure System | Narcotic Usage | 5.32 milligrams of Morphine Equivalence Dose | Standard Deviation 25.08 |
Secondary
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture Wire | Narcotic Usage | 48.32 milligrams of Morphine Equivalence Dose | Standard Deviation 282.77 |
| SternaLock Blu Closure System | Narcotic Usage | 3.00 milligrams of Morphine Equivalence Dose | Standard Deviation 12.72 |
Comparison: From 3 month to 6-month post opp-value: 0.113t-test, 2 sided
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: 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suture Wire | 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 |
| Suture Wire | 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 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 3-month Post Operative | At Rest | 0.39 units on a scale 0-10 | Standard Deviation 1.38 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 3-month Post Operative | After Forced Coughing | 0.74 units on a scale 0-10 | Standard Deviation 1.49 |
Comparison: At Restp-value: 0.6653t-test, 2 sided
Comparison: After Forced Coughingp-value: 0.2295t-test, 2 sided
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: 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suture Wire | 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 |
| Suture Wire | 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 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 3-week Post Operative | At Rest | 0.79 units on a scale 0-10 | Standard Deviation 1.37 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 3-week Post Operative | After Forced Coughing | 1.92 units on a scale 0-10 | Standard Deviation 2.3 |
Comparison: At Restp-value: 0.2125t-test, 2 sided
Comparison: After Forced Coughingp-value: 0.0014t-test, 2 sided
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: 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suture Wire | 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 |
| Suture Wire | 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 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 6-month Post Operative | At Rest | 0.55 units on a scale 0-10 | Standard Deviation 1.43 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 6-month Post Operative | After Forced Coughing | 0.54 units on a scale 0-10 | Standard Deviation 1.26 |
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: 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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suture Wire | 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 |
| Suture Wire | 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 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 6-week Post Operative | At Rest | 0.54 units on a scale 0-10 | Standard Deviation 1.15 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at 6-week Post Operative | After Forced Coughing | 1.26 units on a scale 0-10 | Standard Deviation 1.88 |
Comparison: At Restp-value: 0.0049t-test, 2 sided
Comparison: After Forced Coughingp-value: 0.0183t-test, 2 sided
Secondary
Pain Measured in a 10-point Scale at Day 7 Post Operative
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
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Suture Wire | 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 |
| Suture Wire | 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 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at Day 7 Post Operative | At Rest | 1.07 units on a scale 0-10 | Standard Deviation 1.41 |
| SternaLock Blu Closure System | Pain Measured in a 10-point Scale at Day 7 Post Operative | After Forced Coughing | 2.20 units on a scale 0-10 | Standard Deviation 2.06 |
Comparison: At Restp-value: 0.0539t-test, 2 sided
Comparison: After Forced Coughingp-value: 0.0015t-test, 2 sided