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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical DDD

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ClinicalTrials.gov Identifier: NCT00667459
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : September 22, 2014
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cervical Degenerative Disc Disease
Interventions: Device: PRESTIGE® LP Cervical Disc
Device: ATLANTIS Anterior Cervical Plate

  Participant Flow

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
Investigational PRESTIGE® LP Cervical Disc
Control Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876)

Participant Flow:   Overall Study
    Investigational   Control
STARTED   280   265 
COMPLETED   272   220 
NOT COMPLETED   8   45 
Death                0                2 
Lost to Follow-up                8                43 



  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
Investigational PRESTIGE® LP Cervical Disc
Control Control patients who received ACDF fusion treatment from a previous IDE trial (NCT00642876).
Total Total of all reporting groups

Baseline Measures
   Investigational   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 280   265   545 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (8.8)   43.9  (8.8)   44.2  (8.8) 
Gender 
[Units: Participants]
     
Female   151   143   294 
Male   129   122   251 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   271   243   514 
Black   7   13   20 
Asian   0   2   2 
Hispanic   1   6   7 
Other   1   1   2 
Height 
[Units: In.]
Mean (Standard Deviation)
 67.7  (4.1)   67.5  (4.2)   67.6  (4.2) 
Weight 
[Units: Lbs.]
Mean (Standard Deviation)
 186.9  (45.0)   184.7  (41.5)   185.8  (43.3) 
Marital Status 
[Units: Participants]
     
Single   40   32   72 
Married   189   204   393 
Divorced   42   24   66 
Separated   7   3   10 
Widowed   2   2   4 
Education Level 
[Units: Participants]
     
< High School   15   14   29 
High School   57   77   134 
> High School   206   173   379 
Unknown   2   1   3 
Worker's Compensation Case 
[Units: Participants]
     
Yes   32   35   67 
No   248   230   478 
Unresolved Spinal Litigation 
[Units: Participants]
     
Yes   34   32   66 
No   246   233   479 
Tobacco Used 
[Units: Participants]
     
Yes   74   92   166 
No   206   173   379 
Alcohol Used 
[Units: Participants]
     
Yes   150   141   291 
No   130   124   254 
Preop Work Status 
[Units: Participants]
     
Yes   188   166   354 
No   92   99   191 


  Outcome Measures

1.  Primary:   Rate of Overall Success   [ Time Frame: 24 months ]

2.  Secondary:   Success Rate of Neck Disability Index   [ Time Frame: 24 months ]

3.  Secondary:   Success Rate of Neurological Status   [ Time Frame: 24 months ]

4.  Secondary:   Rate of Disc Height Success   [ Time Frame: 24 months ]

5.  Secondary:   Neck Pain Success Rate   [ Time Frame: 24 months ]

6.  Secondary:   Arm Pain Success Rate   [ Time Frame: 24 months ]

7.  Secondary:   Success Rate of SF-36 PCS   [ Time Frame: 24 months ]

8.  Secondary:   Success Rate of SF-36 MCS   [ Time Frame: 24 months ]

9.  Secondary:   Gait Success Rate   [ Time Frame: 24 months ]

10.  Secondary:   Operative Time   [ Time Frame: Time of operation, approximately 1.5 hrs. ]

11.  Secondary:   Blood Loss   [ Time Frame: During the time of operation, approximately 1.5 hours. ]

12.  Secondary:   Hospital Stay   [ Time Frame: During the time of hospital stay, average of 1 day. ]

13.  Secondary:   Rate of Secondary Surgery at Index Level   [ Time Frame: 24 months post-operation ]

14.  Secondary:   Change of Neck Disability Index Score From Baseline   [ Time Frame: Baseline and 24 months post-operation ]

15.  Secondary:   Change of Neck Pain Score From Baseline   [ Time Frame: Baseline and 24 months post-operation ]

16.  Secondary:   Change of Arm Pain Score From Baseline   [ Time Frame: Baseline and 24 months post-operation ]

17.  Secondary:   Change of General Health Status -- SF-36 PCS From Baseline   [ Time Frame: Baseline and 24 months post-operation ]

18.  Secondary:   Change of General Health Status -- SF-36 MCS From Baseline   [ Time Frame: Baseline and 24 months post-operation ]


  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 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: Clinical Department
Organization: Medtronic Spinal
phone: 1800-876-3133 ext 6068
e-mail: msbkclinicalresearch@medtronic.com


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

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00667459     History of Changes
Other Study ID Numbers: PRESTIGE® LP Protocol, #P03-03
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: August 22, 2014
Results First Posted: September 22, 2014
Last Update Posted: February 5, 2015