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

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ClinicalTrials.gov Identifier: NCT00389597
Recruitment Status : Completed
First Posted : October 19, 2006
Results First Posted : May 1, 2014
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Degenerative Disc Disease
Intervention: Device: Cervical Artificial Disc

  Participant Flow

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

Participant Flow:   Overall Study
    1 Level TDR   1 Level ACDF   2 Level TDR   2 Level ACDF
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

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 Cervical artificial disc (investigational device) at 1 level
1 Level ACDF 1 level control procedure (ACDF)
2 Level TDR Cervical artificial disc (investigational device) at 2 levels
2 Level ACDF 2 level control procedure (ACDF)
Total Total of all reporting groups

Baseline Measures
   1 Level TDR   1 Level ACDF   2 Level TDR   2 Level ACDF   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 164   81   225   105   575 
Age 
[Units: Participants]
Count of Participants 		         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      161  98.2%      80  98.8%      222  98.7%      101  96.2%      564  98.1% 
>=65 years      3   1.8%      1   1.2%      3   1.3%      4   3.8%      11   1.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		         
Female      86  52.4%      45  55.6%      112  49.8%      45  42.9%      288  50.1% 
Male      78  47.6%      36  44.4%      113  50.2%      60  57.1%      287  49.9% 
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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT00389597     History of Changes
Other Study ID Numbers: LDR-001
First Submitted: October 18, 2006
First Posted: October 19, 2006
Results First Submitted: January 3, 2014
Results First Posted: May 1, 2014
Last Update Posted: December 11, 2017