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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT00432159
First received: February 5, 2007
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   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  
Number of Participants  
[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  
Gender  
[units: participants]
           
Female     93     89     26     10     42     260  
Male     92     78     13     10     47     240  
Ethnicity (NIH/OMB)  
[units: participants]
           
Hispanic or Latino     7     4     1     1     1     14  
Not Hispanic or Latino     172     153     38     19     88     470  
Unknown or Not Reported     6     10     0     0     0     16  
Race (NIH/OMB)  
[units: participants]
           
American Indian or Alaska Native     0     1     0     0     1     2  
Asian     1     2     1     0     1     5  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0  
Black or African American     8     6     1     2     4     21  
White     170     147     36     18     82     453  
More than one race     0     0     0     0     1     1  
Unknown or Not Reported     6     11     1     0     0     18  
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
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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
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


No publications provided


Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT00432159     History of Changes
Other Study ID Numbers: 06-DISCOVER
Study First Received: February 5, 2007
Results First Received: May 27, 2014
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration