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

History of Changes

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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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 ]

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2. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Principal investigator may publish his/her own results from the study provided such publication does not include or disclose any confidential information. Principal investigator may also participate in joint publications. All proposed publications shall be submitted to Biomet for review. Biomet will have 30 days to review the proposed publication.

Limitations and Caveats

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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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

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