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Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00291018
First received: February 10, 2006
Last updated: January 17, 2017
Last verified: January 2017
Results First Received: November 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Symptomatic Cervical Disc Disease
Interventions: Device: Total Disc Replacement
Device: ACDF

  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
Not all subjects who were Enrolled were also Treated. Subjects were Enrolled if they met all Inclusion/Exclusion criteria for the study. However, some subjects were Enrolled who were never Treated. Reasons for subjects to be Enrolled but not Treated include subject's insurance would not cover the procedure, subject changed mind, etc.

Reporting Groups
  Description
ProDisc-C

ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7

Total Disc Replacement

Randomized Group

Control

Anterior Cervical Discectomy and Fusion

ACDF

Randomized Group

ProDisc-C Continued Access

ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7

Total Disc Replacement

Non-Randomized Group


Participant Flow:   Overall Study
    ProDisc-C   Control   ProDisc-C Continued Access
STARTED   103 [1]   106 [2]   136 [3] 
Evaluated at 24 Months   99   92   105 
COMPLETED   78 [4]   64 [4]   93 [4] 
NOT COMPLETED   25   42   43 
Not Consented or Declined PAS                12                15                15 
Death                3                3                4 
Withdrawal by Subject                2                8                1 
Failures                5                12                5 
Lost to Follow-up                3                4                18 
[1] Started = Subjects Enrolled and Treated. 111 PDC subjects were Enrolled but only 103 were Treated
[2] Started = Subjects Enrolled and Treated. 117 ACDF subjects were Enrolled but only 106 were Treated
[3] Started =Subjects Enrolled and Treated. 140 PDC-CA subjects were Enrolled but only 136 were Treated
[4] Evaluated at 84 Months



  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.
Number of subjects enrolled and treated

Reporting Groups
  Description
ProDisc-C

ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7

Total Disc Replacement

Randomized

Control

Anterior Cervical Discectomy and Fusion

ACDF

Randomized

ProDisc-C Continued Access

ProDisc-C total disc replacement device intended to treat single level SCDD in the cervical spine from C3-C7

Total Disc Replacement

Non-Randomized

Total Total of all reporting groups

Baseline Measures
   ProDisc-C   Control   ProDisc-C Continued Access   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   106   136   345 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 42.1  (8.42)   43.5  (7.15)   43.4  (7.95)   43.0  (7.84) 
[1] age at time of enrollment into the study
Gender 
[Units: Participants]
Count of Participants
       
Female      57  55.3%      57  53.8%      78  57.4%      192  55.7% 
Male      46  44.7%      49  46.2%      58  42.6%      153  44.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      5   4.9%      0   0.0%      5   3.7%      10   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   3.9%      1   0.9%      0   0.0%      5   1.4% 
White      88  85.4%      97  91.5%      125  91.9%      310  89.9% 
More than one race      3   2.9%      5   4.7%      2   1.5%      10   2.9% 
Unknown or Not Reported      3   2.9%      3   2.8%      4   2.9%      10   2.9% 
Region of Enrollment 
[Units: Subjects]
       
United States   103   106   136   345 
Smoking Status 
[Units: Subjects]
       
Never   51   49   79   179 
Former   18   20   30   68 
Current   34   37   27   98 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.4  (5.32)   27.3  (5.54)   26.6  (5.07)   26.8  (5.31) 
Duration of Neck/Arm Pain 
[Units: Subjects]
       
< 6 weeks   3   3   1   7 
6 weeks to 1 year   44   44   49   137 
> 1 year   56   59   86   201 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Success   [ Time Frame: 84 Months ]

2.  Secondary:   Neurologic Success   [ Time Frame: 84 months ]

3.  Secondary:   NDI   [ Time Frame: 84 months ]

4.  Secondary:   SF-36 Physical Composite Score (PCS)   [ Time Frame: 84 Months ]

5.  Secondary:   SF-36 Mental Composite Score (MCS)   [ Time Frame: 84 Months ]

6.  Secondary:   Visual Analog Scale (VAS) Satisfaction   [ Time Frame: 84 Months ]

7.  Secondary:   Visual Analog Scale (VAS) Neck Pain Intensity   [ Time Frame: 84 Months ]

8.  Secondary:   Visual Analog Scale (VAS) Neck Pain Frequency   [ Time Frame: 84 Months ]

9.  Secondary:   Visual Analog Scale (VAS) Arm Pain Intensity   [ Time Frame: 84 Months ]

10.  Secondary:   Visual Analog Scale (VAS) Arm Pain Frequency   [ Time Frame: 84 Months ]

11.  Secondary:   Surgery Again   [ Time Frame: 84 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
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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 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: Erin Prifogle
Organization: DePuy Synthes Spine
phone: 508-977-6451
e-mail: eprifog1@its.jnj.com


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

Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00291018     History of Changes
Other Study ID Numbers: PDC-08122003
Study First Received: February 10, 2006
Results First Received: November 17, 2016
Last Updated: January 17, 2017