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PCM Cervical Disc System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00578812
First received: December 19, 2007
Last updated: April 21, 2014
Last verified: April 2014
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Radiculopathy
Myelopathy
Interventions: Device: Anterior Cervical Discectomy and Fusion (ACDF)
Device: PCM Cervical Disc

  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
Each clinical site could treat up to two (2) non-randomized investigational training patients prior to entering the randomized phase of the clinical trial.

Reporting Groups
  Description
PCM Cervical Disc - Investigational PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Anterior Cervical Discectomy and Fusion - Control Group Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1

Participant Flow:   Overall Study
    PCM Cervical Disc - Investigational     Anterior Cervical Discectomy and Fusion - Control Group  
STARTED     224 [1]   192  
COMPLETED     218 [2]   185  
NOT COMPLETED     6     7  
Not treated                 6                 7  
[1] Does not include investigational training patients (78 STARTED, 76 COMPLETED, 2 Not Treated).
[2] Modified Intent-to-Treat (treated patients; analyzed as randomized).



  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.
No text entered.

Reporting Groups
  Description
PCM Cervical Disc - Investigational PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Anterior Cervical Discectomy and Fusion - Control Group Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
Total Total of all reporting groups

Baseline Measures
    PCM Cervical Disc - Investigational     Anterior Cervical Discectomy and Fusion - Control Group     Total  
Number of Participants  
[units: participants]
  218     185     403  
Age  
[units: years]
Mean ± Standard Deviation
  45.3  ± 9.0     43.7  ± 8.3     44.5  ± 8.7  
Gender  
[units: participants]
     
Female     105     89     194  
Male     113     96     209  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     202     170     372  
Black     10     7     17  
Asian     0     5     5  
Hispanic     3     2     5  
Other     3     1     4  
Region of Enrollment  
[units: participants]
     
United States     218     185     403  



  Outcome Measures
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1.  Primary:   Individual Patient Overall Success   [ Time Frame: 24 Months ]

2.  Secondary:   Neck Pain Visual Analog Scale   [ Time Frame: 24 Months ]

3.  Secondary:   Mean Neck Pain Visual Analog Scale   [ Time Frame: 24 Months ]

4.  Secondary:   Worst Arm Pain Visual Analog Scale   [ Time Frame: 24 Months ]

5.  Secondary:   Mean Worst Arm Pain Visual Analog Scale   [ Time Frame: 24 Months ]

6.  Secondary:   Clinically Significant Improvement on Neck Disability Index (NDI)   [ Time Frame: 24 Months ]

7.  Secondary:   Clinically Significant Improvement on Neck Disability Index (NDI)   [ Time Frame: 24 Months ]

8.  Secondary:   Mean Neck Disability Index (NDI)   [ Time Frame: 24 Months ]

9.  Secondary:   Clinically Significant Improvement on SF-36 Physical Component Summary (PCS)   [ Time Frame: 24 Months ]

10.  Secondary:   Mean SF-36 Physical Component Summary (PCS)   [ Time Frame: 24 Months ]

11.  Secondary:   Clinically Significant Improvement on SF-36 Mental Component Summary (MCS)   [ Time Frame: 24 Months ]

12.  Secondary:   Mean SF-36 Mental Component Summary (MCS)   [ Time Frame: 24 Months ]

13.  Secondary:   Dysphagia for Swallowing   [ Time Frame: 24 Months ]

14.  Secondary:   Patient Satisfaction   [ Time Frame: 24 Months ]

15.  Secondary:   Nurick's Classification of Disability (Myelopathy)   [ Time Frame: 24 Months ]

16.  Secondary:   Flexion/Extension Range of Motion at the Operative Level   [ 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
None


  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 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: Mandy Wright, Sr. Clinical Affairs Associate
Organization: NuVasive, Inc
phone: 858-349-6581
e-mail: mwright@nuvasive.com


No publications provided


Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00578812     History of Changes
Other Study ID Numbers: G040081
Study First Received: December 19, 2007
Results First Received: November 29, 2012
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration