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Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

This study has been terminated.
(Greater-than-anticipated rate of revisions)
Sponsor:
Information provided by (Responsible Party):
Orthofix Inc.
ClinicalTrials.gov Identifier:
NCT00637312
First received: March 10, 2008
Last updated: February 12, 2014
Last verified: February 2014
Results First Received: February 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cervical Degenerative Disc Disease
Interventions: Device: Cervical Artificial Disc (Advent™ Cervical Disc)
Device: Hallmark™ Anterior Cervical Plate System

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Advent™ Cervical Disc Cervical artificial disc replacement: Advent™ Cervical Disc
Standard Care - Control Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System

Participant Flow:   Overall Study
    Advent™ Cervical Disc     Standard Care - Control  
STARTED     72     36  
COMPLETED     30     19  
NOT COMPLETED     42     17  



  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
Advent™ Cervical Disc Cervical artificial disc replacement: Advent™ Cervical Disc
Standard Care - Control Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System
Total Total of all reporting groups

Baseline Measures
    Advent™ Cervical Disc     Standard Care - Control     Total  
Number of Participants  
[units: participants]
  72     36     108  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     72     36     108  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 8.5     45.6  ± 9.1     43.9  ± 8.7  
Gender  
[units: participants]
     
Female     36     19     55  
Male     36     17     53  
Region of Enrollment  
[units: participants]
     
United States     72     36     108  



  Outcome Measures

1.  Primary:   Evaluation of Device and/or Procedure Related Adverse Event(s)   [ Time Frame: At 24-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
The study was suspended for a high rate of adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent group. Approval is not being pursued and thus no analysis has been completed.


  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: Ruba Sarris
Organization: Orthofix
phone: 214-937-2256
e-mail: rubasarris@orthofix.com


No publications provided


Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT00637312     History of Changes
Other Study ID Numbers: CP-01003
Study First Received: March 10, 2008
Results First Received: February 12, 2014
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration