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Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432159
First Posted: February 7, 2007
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy Spine
Results First Submitted: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Cervical Degenerative Disc Disease
Interventions: Device: Cervical TDR
Device: ACDF with plate

  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
First subject was enrolled on July 10, 2006. The final study subjects were enrolled on March 22, 2011 and all study sites were informed that enrollment was closed effective March 31, 2011.

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
1-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
1-level ACDF With Plate Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
2-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
2-level ACDF Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Training: 1 & 2-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

Participant Flow:   Overall Study
    1-level Cervical TDR   1-level ACDF With Plate   2-level Cervical TDR   2-level ACDF   Training: 1 & 2-level Cervical TDR
STARTED   185   167   39   20   89 
COMPLETED   163 [1]   137 [1]   35 [1]   15 [1]   79 [1] 
NOT COMPLETED   22   30   4   5   10 
Death                0                1                0                0                0 
Failure                9                5                3                2                3 
Missing NDI and/or neuro. assessment                13                24                1                3                7 
[1] Actual (Complete efficacy)



  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.
Intent-to-treat

Reporting Groups
  Description
1-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
1-level ACDF With Plate Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
2-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
2-level ACDF Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive. ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.
Training: 1 & 2-level Cervical TDR Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort. Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
Total Total of all reporting groups

Baseline Measures
   1-level Cervical TDR   1-level ACDF With Plate   2-level Cervical TDR   2-level ACDF   Training: 1 & 2-level Cervical TDR   Total 
Overall Participants Analyzed 
[Units: Participants]
 185   167   39   20   89   500 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.2  (8.63)   42.8  (7.63)   44.1  (7.94)   44.4  (7.74)   42.3  (7.49)   43.4  (8.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      93  50.3%      89  53.3%      26  66.7%      10  50.0%      42  47.2%      260  52.0% 
Male      92  49.7%      78  46.7%      13  33.3%      10  50.0%      47  52.8%      240  48.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
           
Hispanic or Latino      7   3.8%      4   2.4%      1   2.6%      1   5.0%      1   1.1%      14   2.8% 
Not Hispanic or Latino      172  93.0%      153  91.6%      38  97.4%      19  95.0%      88  98.9%      470  94.0% 
Unknown or Not Reported      6   3.2%      10   6.0%      0   0.0%      0   0.0%      0   0.0%      16   3.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      1   0.6%      0   0.0%      0   0.0%      1   1.1%      2   0.4% 
Asian      1   0.5%      2   1.2%      1   2.6%      0   0.0%      1   1.1%      5   1.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8   4.3%      6   3.6%      1   2.6%      2  10.0%      4   4.5%      21   4.2% 
White      170  91.9%      147  88.0%      36  92.3%      18  90.0%      82  92.1%      453  90.6% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   1.1%      1   0.2% 
Unknown or Not Reported      6   3.2%      11   6.6%      1   2.6%      0   0.0%      0   0.0%      18   3.6% 
BMI [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 28.3  (4.97)   27.6  (4.83)   28.3  (4.97)   30.0  (3.61)   28.9  (5.12)   28.3  (4.9) 
[1] Body Mass Index in units of kilogram per meter squared


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   NDI Success   [ Time Frame: 24 months ]

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

4.  Secondary:   Subsequent Secondary Surgery Component of Success   [ Time Frame: 24 months ]

5.  Secondary:   Device-Related SAE Component of Success   [ Time Frame: 24 months ]

6.  Secondary:   NDI - Change From Baseline   [ Time Frame: 24 months ]

7.  Secondary:   Neck Pain VAS Scores - Change From Baseline   [ Time Frame: 24 months ]

8.  Secondary:   Maximum Arm Pain VAS - Change From Baseline   [ Time Frame: 24 months ]

9.  Secondary:   Average Arm Pain VAS - Change From Baseline   [ Time Frame: 24 months ]

10.  Secondary:   Maximum Shoulder Pain VAS - Change From Baseline   [ Time Frame: 24 months ]

11.  Secondary:   Average Shoulder Pain VAS - Change From Baseline   [ Time Frame: 24 months ]

12.  Secondary:   Dysphagia Disability Index - Change From Baseline   [ Time Frame: 24 months ]

13.  Secondary:   SF-36 - Physical Composite Scores (PCS) - Change From Baseline   [ Time Frame: 24 months ]

14.  Secondary:   SF-36 - Mental Composite Scores (MCS) - Change From Baseline   [ Time Frame: 24 months ]

15.  Secondary:   Work Status Assessment   [ Time Frame: 24 months ]

16.  Secondary:   Return to Work   [ Time Frame: 24 months ]

17.  Secondary:   Activity   [ Time Frame: 24 months ]

18.  Secondary:   Subject Satisfaction   [ Time Frame: 24 months ]

19.  Secondary:   Global Cervical Range of Motion - Change From Baseline   [ Time Frame: 24 months ]

20.  Secondary:   Average Radiographic Disc Height (mm) - Change From Post-op   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Enrollment terminated early, and beginning in March 2013, follow-up visits beyond 24 months were limited to Discover subjects only.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Lynn Wilson
Organization: Depuy Synthes
phone: 508-880-8109
e-mail: lwilso45@its.jnj.com



Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT00432159     History of Changes
Other Study ID Numbers: 06-DISCOVER
First Submitted: February 5, 2007
First Posted: February 7, 2007
Results First Submitted: May 27, 2014
Results First Posted: August 7, 2014
Last Update Posted: October 20, 2017