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Study of SyntheCelTM Dura Replacement to Other Dura Replacements

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00859508
First received: March 6, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
Results First Received: February 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cranial Dura Repair
Interventions: Device: SyntheCel
Device: Other FDA cleared dura replacements

  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
The trial was approved to enroll subjects from a maximum of 10 US medical institutions (public and academic research center hospitals). Subjects were enrolled from February 2006 to June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 105 patients that initially met the inclusion/exclusion criteria were enrolled and randomized. Of those 105 patients, 99 received surgical treatment. Of those not treated, reasons included: change in diagnosis, not meeting Inclusion/Exclusion criteria, subject voluntary withdrawl, and investigator decision.

Reporting Groups
  Description
SyntheCel The investigational group consists of patients who received the SyntheCel Dura Replacement device.
Other FDA Cleared Dura Replacements The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.

Participant Flow:   Overall Study
    SyntheCel     Other FDA Cleared Dura Replacements  
STARTED     68     37  
COMPLETED     62     37  
NOT COMPLETED     6     0  



  Baseline Characteristics
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Reporting Groups
  Description
SyntheCel The investigational group consists of patients who received the SyntheCel Dura Replacement device.
Other FDA Cleared Dura Replacements The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
Total Total of all reporting groups

Baseline Measures
    SyntheCel     Other FDA Cleared Dura Replacements     Total  
Number of Participants  
[units: participants]
 		  68     37     105  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     61     31     92  
>=65 years     7     6     13  
Age  
[units: years]
Mean ± Standard Deviation 		  46.5  ± 12.85     48.6  ± 14.03     47.2  ± 13.25  
Gender  
[units: participants]
 		     
Female     50     25     75  
Male     18     12     30  
Region of Enrollment  
[units: participants]
 		     
United States     68     37     105  



  Outcome Measures

1.  Primary:   Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Modified Rankin Scale (Patient Function Assessment)   [ Time Frame: up to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)   [ Time Frame: up to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Wound Healing Assessment   [ Time Frame: up to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)   [ Time Frame: up to 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Radiographic Evaluation   [ Time Frame: 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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:
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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Heidi Hausner, Clinical Research Manager
Organization: Synthes USA HQ, Inc.
phone: 610-719-5707
e-mail: hausner.heidi@synthes.com


Publications of Results:


Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00859508     History of Changes
Obsolete Identifiers: NCT00454844
Other Study ID Numbers: SyntheCel
Study First Received: March 6, 2009
Results First Received: February 3, 2012
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration