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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01783483
First Posted: February 5, 2013
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
Results First Submitted: December 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Conditions: Coronary Artery Disease
Angina Pectoris
Cardiac Valve Disease
Interventions: Device: SternaLock Blue closure system
Device: Suture Wire

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Suture Wire   SternaLock Blu Closure System
STARTED   120   116 
COMPLETED   100   101 
NOT COMPLETED   20   15 
Death                3                3 
Lost to Follow-up                14                10 
Withdrawal by Subject                2                1 
Physician Decision                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 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

Total Total of all reporting groups

Baseline Measures
   Suture Wire   SternaLock Blu Sternal Closure System   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   116   236 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.7  (11.4)   65.3  (13.0)   65.5  (12.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      29  24.2%      30  25.9%      59  25.0% 
Male      91  75.8%      86  74.1%      177  75.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White/Caucasian   102   103   205 
Black/African American   12   7   19 
Hispanic/Latino   5   4   9 
Asian   0   1   1 
Not Given   0   1   1 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.4  (4.6)   28.8  (4.7)   29.1  (4.7) 
Risk Factor [Diabetes] 
[Units: Participants]
Count of Participants
 44   35   79 
Risk Factor [Renal Failure] 
[Units: Participants]
Count of Participants
 2   0   2 
Risk Factor [Current Cigarette Smoker] 
[Units: Participants]
Count of Participants
 10   14   24 
Risk Factor [Hypertension] 
[Units: Participants]
Count of Participants
 83   86   169 
Risk Factor [Chronic Lung Disease] 
[Units: Participants]
Count of Participants
     
Mild      15  12.5%      18  15.5%      33  14.0% 
Moderate      7   5.8%      4   3.4%      11   4.7% 
Severe      0   0.0%      0   0.0%      0   0.0% 
None      98  81.7%      94  81.0%      192  81.4% 
Risk Factor [Previous Sternotomy] 
[Units: Participants]
Count of Participants
 5   8   13 
Risk Factor [Ejection Fraction] 
[Units: Percentage]
Mean (Standard Deviation)
 55.4  (11.3)   55.2  (11.9)   55.3  (11.6) 
Risk Factor [Congestive Heart Failure by NYHA Classification] [1] 
[Units: Participants]
Count of Participants
     
Class I - No limitation of physical activity      17  14.2%      10   8.6%      27  11.4% 
Class II - Slight limitation of physical activity      27  22.5%      21  18.1%      48  20.3% 
Class III - Marked limitation of physical activity      11   9.2%      15  12.9%      26  11.0% 
None (No heart failure present)      65  54.2%      70  60.3%      135  57.2% 
[1] The New York Heart Association (NYHA) classifies heart failure according to the severity of patients' symptoms. Grades I through 4 of heart failure by NYHA is a functional classification, placing patients in one of four categories based on how much they are limited during physical activity. Grade I represents better outcome since there is no limitation of physical activities while Grade IV (exclusionary for this trial) represents the worst outcome, since patients are unable to carry on any physical activity without discomfort, even at rest.
Risk Factor [Peripheral Artery Disease] 
[Units: Participants]
Count of Participants
 5   12   17 
Risk Factor [Cerebral Vascular Disease] 
[Units: Participants]
Count of Participants
 7   10   17 
Risk Factor [Left Main Disease] 
[Units: Participants]
Count of Participants
 24   26   50 
Risk Factor [Previous Myocardial Infarction] 
[Units: Participants]
Count of Participants
     
More than 6h but less than 24h      0   0.0%      3   2.6%      3   1.3% 
More than 1 day but less than 7 days      2   1.7%      4   3.4%      6   2.5% 
More than 8 days but less than 21 days      18  15.0%      16  13.8%      34  14.4% 
More than 21 days      0   0.0%      1   0.9%      1   0.4% 
None or Never      100  83.3%      92  79.3%      192  81.4% 
Inspirometry Volume 
[Units: mL]
Mean (Standard Deviation)
 2436.3  (931.1)   2398.7  (1025.7)   2417.8  (976.8) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing   [ Time Frame: 3-month post-op ]

2.  Primary:   Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing   [ Time Frame: 6-month post-op ]

3.  Secondary:   Pain Measured in a 10-point Scale at Day 7 Post Operative   [ Time Frame: Day 7 ]

4.  Secondary:   Pain Measured in a 10-point Scale at 3-week Post Operative   [ Time Frame: 3-week Post-op ]

5.  Secondary:   Pain Measured in a 10-point Scale at 6-week Post Operative   [ Time Frame: 6-week Post-op ]

6.  Secondary:   Pain Measured in a 10-point Scale at 3-month Post Operative   [ Time Frame: 3-month Post-op ]

7.  Secondary:   Pain Measured in a 10-point Scale at 6-month Post Operative   [ Time Frame: 6-month Post-op ]

8.  Secondary:   Narcotic Usage   [ Time Frame: Index (Day 0 to Hospital Discharge) ]

9.  Secondary:   Narcotic Usage   [ Time Frame: From Hospital Discharge to 3-week post-op ]

10.  Secondary:   Narcotic Usage   [ Time Frame: From 3-week to 6-week post-op ]

11.  Secondary:   Narcotic Usage   [ Time Frame: From 6-week to 3-month post-op ]

12.  Secondary:   Narcotic Usage   [ Time Frame: From 3-month to 6 month post-op ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
At closing of this study, only 2 prospective RCTs have been conducted that compare RPF with WC. Because both were done with first and second generation devices from the same manufacturer, conclusions on the class effect of RPF systems cannot be made.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brian M Hatcher, PhD
Organization: Zimmer Biomet
phone: 904-741-4400
e-mail: brian.hatcher@zimmerbiomet.com


Publications:


Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01783483     History of Changes
Other Study ID Numbers: 0712
SLBlu ( Other Identifier: Biomet Microfixation )
First Submitted: January 31, 2013
First Posted: February 5, 2013
Results First Submitted: December 16, 2016
Results First Posted: September 8, 2017
Last Update Posted: September 8, 2017