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An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CeraPedics, Inc
ClinicalTrials.gov Identifier:
NCT00310440
First received: April 3, 2006
Last updated: January 13, 2016
Last verified: January 2016
History of Changes
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Intervertebral Disk Degeneration
Interventions: Device: P-15 Synthetic osteoconductive bone substitute
Other: Autologous bone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bone Graft Substitute

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
Autologous Bone

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring

Participant Flow:   Overall Study
    Bone Graft Substitute     Autologous Bone  
STARTED     165     154  
COMPLETED     139     141  
NOT COMPLETED     26     13  
Lost to Follow-up                 17                 8  
Withdrawal by Subject                 2                 1  
Missed 12 Month Visit                 7                 4  



  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
Bone Graft Substitute

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).

P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery
Autologous Bone

Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.

Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring
Total Total of all reporting groups

Baseline Measures
    Bone Graft Substitute     Autologous Bone     Total  
Number of Participants  
[units: participants]
 		  165     154     319  
Age  
[units: years]
Mean (Standard Deviation) 		  47.7  (9.7)     45.7  (9.4)     46.8  (9.6)  
Gender  
[units: participants]
 		     
Female     95     97     192  
Male     70     57     127  
Ethnicity (NIH/OMB)  
[units: participants]
 		     
Hispanic or Latino     7     4     11  
Not Hispanic or Latino     157     150     307  
Unknown or Not Reported     1     0     1  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     1     0     1  
Asian     4     1     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     6     11  
White     151     144     295  
More than one race     0     0     0  
Unknown or Not Reported     4     3     7  
Region of Enrollment  
[units: participants]
 		     
Canada     29     26     55  
United States     136     128     264  



  Outcome Measures
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1.  Primary:   Radiologic Fusion   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Primary:   Change in of the Overall Neck Disability Index (NDI) Score From Baseline.   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Primary:   Neurologic Success   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Primary:   Complications   [ Time Frame: 12 months ]
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5.  Secondary:   Mean Change in Pain at Neck Visual Analog Scale (VAS).   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change at Pain at Arm and Shoulder Visual Analog Scale (VAS).   [ Time Frame: Baseline and 12 months ]
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7.  Secondary:   Success Rates Measured by Aggregated Modified Odom's Criteria   [ Time Frame: 12 months ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change in the Short Form 36 v2 (SF-36v2) Physical Composite Score (PCS).   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change in the Short Form 36 v2 (SF-36v2) Mental Health Composite Score (MCS).   [ Time Frame: Baseline and 12 months ]
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10.  Secondary:   Kyphosis   [ Time Frame: 12 months ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  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 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.


Results Point of Contact:  
Name/Title: Lead Clinical Research Associate
Organization: Nor Consult, LLC
phone: 2066076861
e-mail: p15@nor-consult.com



Responsible Party: CeraPedics, Inc
ClinicalTrials.gov Identifier: NCT00310440     History of Changes
Other Study ID Numbers: 1003
Study First Received: April 3, 2006
Results First Received: December 10, 2015
Last Updated: January 13, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada