Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain (RESTORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00819286
First received: January 6, 2009
Last updated: May 1, 2013
Last verified: May 2013
Results First Received: December 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Sternal Wound Infection
Sternal Non-union
Pain
Mediastinitis
Interventions: Device: SternaLock Rigid Fixation System
Device: Wire (control)

  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
Prospective, randomized trial at 5 US sites and 1 European site. Patient enrollment occurred between November 2008 and May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were randomized at the time of sternal closure to either rigid plate fixation or wire cerclage. A total of 140 patients were enrolled in this study (70 in each treatment group) and included in an intent to treat analysis.

Reporting Groups
  Description
Wire (Control) patients will have their sternum closed using stainless steel wires.
Plates patients will have their sternum closed by rigid fixation using SternaLock plates.

Participant Flow:   Overall Study
    Wire (Control)     Plates  
STARTED     70     70  
COMPLETED     56     45  
NOT COMPLETED     14     25  



  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.
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Reporting Groups
  Description
Wire (Control) patients will have their sternum closed using stainless steel wires.
Plates patients will have their sternum closed by rigid fixation using SternaLock plates.
Total Total of all reporting groups

Baseline Measures
    Wire (Control)     Plates     Total  
Number of Participants  
[units: participants]
  70     70     140  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.9     66.3  ± 9.8     65.2  ± 9.4  
Gender  
[units: participants]
     
Female     18     19     37  
Male     52     51     103  



  Outcome Measures
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1.  Primary:   CT Scan Evaluation of Sternal Bone Healing   [ Time Frame: 3 and 6 Months ]

2.  Primary:   Activity Based Total Visual Analog Pain Score   [ Time Frame: 6 months ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Brian Hatcher
Organization: Biomet Microfixation
phone: 904-741-4400
e-mail: brian.hatcher@biomet.com


No publications provided


Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00819286     History of Changes
Other Study ID Numbers: 07071
Study First Received: January 6, 2009
Results First Received: December 27, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices