C-Tek™ Fusion Study

This study has been terminated.
(Due to lack of follow-up information)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:
NCT00585923
First received: December 21, 2007
Last updated: May 1, 2012
Last verified: May 2012
Results First Received: November 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Herniated Disc
Radiculopathy
Spondylolysis
Intervention: Device: C-Tek™ Plate

  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
Recruitment was done through the population of Dr. Nunley's practice. Once Dr. Nunley decided that the patient was a candidate for cervical fusion, he discussed the study with the patient. After subject signed the informed consent subject was randomized to the Slotted Hole or the Fixed Hole C Tek™ Anterior Cervical Plate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were included in this study if the answer to all of the inclusion criteria was yes and the answer to all of the exclusion questions was no.

Reporting Groups
  Description
Fixed Hole C-Tek Plate Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate Slotted Hole C-Tek Plate for ACDF

Participant Flow:   Overall Study
    Fixed Hole C-Tek Plate     Slotted Hole C-Tek Plate  
STARTED     56     59  
COMPLETED     25     26  
NOT COMPLETED     31     33  
Physician decided not to continue                 31                 33  



  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
Fixed Hole C-Tek Plate Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
Slotted Hole C-Tek Plate Slotted Hole C-Tek Plate for ACDF
Total Total of all reporting groups

Baseline Measures
    Fixed Hole C-Tek Plate     Slotted Hole C-Tek Plate     Total  
Number of Participants  
[units: participants]
  56     59     115  
Age [1]
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     50     96  
>=65 years     5     7     12  
Age  
[units: years]
Mean ± Standard Deviation
  49.46  ± 10.26     50.03  ± 10.04     49.76  ± 10.10  
Gender  
[units: participants]
     
Female     32     34     66  
Male     24     25     49  
[1] There were 5 patients in the fixed hole group and 2 patients in the slotted hole group who do not have calculated age due to missing information that we were unable to obtain from the clinical site



  Outcome Measures
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1.  Primary:   Fusion Success   [ Time Frame: Last Follow-Up (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ]

2.  Secondary:   Pain at Rest   [ Time Frame: Baseline and Last Follow-Up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ]

3.  Secondary:   Pain With Activity   [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ]

4.  Secondary:   Neurological Status Change in Neurological Status Since Surgery.   [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ]

5.  Secondary:   Level of Function (Neck Disability Index)   [ Time Frame: Baseline and Last follow-up visit (Last follow-up ranged from no visit after surgery to 24 months of follow-up) ]


  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
Early termination of this study because the doctor involved in the study decided that he did not want to participate in the study any more. The site also did not have very good follow-up on all of their patients


  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: Jacquelyn Hughes
Organization: Biomet
phone: 973-299-9300 ext 3075
e-mail: jacquelyn.hughes@biomet.com


No publications provided


Responsible Party: Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier: NCT00585923     History of Changes
Other Study ID Numbers: CS-014
Study First Received: December 21, 2007
Results First Received: November 11, 2009
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board