LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA
ClinicalTrials.gov Identifier:
NCT00389597
First received: October 18, 2006
Last updated: April 1, 2014
Last verified: April 2014
Results First Received: January 3, 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: Degenerative Disc Disease
Intervention: Device: Cervical Artificial Disc

  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
One Level TDR Arm: 169 subjects randomized (5 not operated) One Level ACDF Arm: 87 subjects randomized (6 not operated) Two level TDR arm: 232 subjects randomized (7 not operated). Two Level ACDF Arm: 115 subjects randomized (10 not operated)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 level TDR enrolled 184 incl15 training cases (2 withdrew consent, 1 AE, 2 other). 1 level ACDF enrolled 87 with no training cases (4 withdrew consent, 2 other) for 245 randomized subjects. 2 level TDR enrolled 241 incl. 9 training cases (1 withdrew consent, 6 other); 2 Level ACDF enrolled 115 with no training cases (4 withdrew consent, 6 other)

Reporting Groups
  Description
1 Level TDR Arm Cervical artificial disc (investigational device) at 1 level
1 Level ACDF Arm 1 level control procedure (ACDF)
2 Level TDR Arm Cervical artificial disc (investigational device) at 2 levels
2 Level ACDF Arm 2 level control procedure (ACDF)

Participant Flow:   Overall Study
    1 Level TDR Arm     1 Level ACDF Arm     2 Level TDR Arm     2 Level ACDF Arm  
STARTED     164     81     225     105  
24 mo     156     75     221     99  
COMPLETED     156     75     221     99  
NOT COMPLETED     8     6     4     6  
Lost to Follow-up                 8                 6                 4                 6  



  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
1 Level TDR No text entered.
1 Level ACDF No text entered.
2 Level TDR No text entered.
2 Level ACDF No text entered.
Total Total of all reporting groups

Baseline Measures
    1 Level TDR     1 Level ACDF     2 Level TDR     2 Level ACDF     Total  
Number of Participants  
[units: participants]
  164     81     225     105     575  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     161     80     222     101     564  
>=65 years     3     1     3     4     11  
Age  
[units: years]
Mean ± Standard Deviation
         
<=18 years     0  ± 0     0  ± 0     0  ± 0     0  ± 0     0  ± 0  
Between 18 and 65 years     43.8  ± 7.9     42.9  ± 8.8     45.4  ± 7.1     45.8  ± 7.8     44.3  ± 8.0  
>=65 years     65.0  ± 1.0     66.0  ± 1.0     65.5  ± 0.6     66.0  ± 1     65.7  ± 0.8  
Gender  
[units: participants]
         
Female     86     45     112     45     288  
Male     78     36     113     60     287  
Region of Enrollment  
[units: participants]
         
United States     164     81     225     105     575  



  Outcome Measures

1.  Primary:   Composite Definition of Study Success   [ Time Frame: 2 Years ]


  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
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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 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: Noah Bartsch, VP, Clinical,Regulatory,Quality
Organization: LDR Spine
phone: 512-344-3319
e-mail: noah.bartsch@ldrspine.com


Publications of Results:

Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT00389597     History of Changes
Other Study ID Numbers: LDR-001
Study First Received: October 18, 2006
Results First Received: January 3, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration