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Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (COLD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halyard Health
ClinicalTrials.gov Identifier:
NCT01263054
First received: November 29, 2010
Last updated: February 11, 2016
Last verified: March 2015
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Back Pain
Interventions: Device: TransDiscal System
Other: Medical Management

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In this study, 67 subjects were randomized, with 63/67 being treated. Three of the non-treated subjects had exclusion criteria violations, while the fourth subject was not treated for an undisclosed reason. The disposition of subjects in the Participant Flow summary is with respect to the primary outcome.

Reporting Groups
  Description
TransDiscal System

Kimberly-Clark TransDiscal System in addition to standard medical management

TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.

Medical Management

Standard medical management

Medical Management: Standard medical management, physical therapy, and lifestyle changes.


Participant Flow:   Overall Study
    TransDiscal System   Medical Management
STARTED   29   34 
COMPLETED   24   28 
NOT COMPLETED   5   6 
Death                1                0 
Lost to Follow-up                2                2 
Withdrawal by Subject                1                3 
Qualification Violation                1                0 
Other                0                1 



  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
TransDiscal System

Kimberly-Clark TransDiscal System in addition to standard medical management

TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty.

Medical Management

Standard medical management

Medical Management: Standard medical management, physical therapy, and lifestyle changes.

Total Total of all reporting groups

Baseline Measures
   TransDiscal System   Medical Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   34   63 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   28   34   62 
>=65 years   1   0   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 41  (11)   43  (11)   42  (11) 
Gender 
[Units: Participants]
     
Female   16   19   35 
Male   13   15   28 
Region of Enrollment 
[Units: Participants]
     
United States   29   34   63 


  Outcome Measures
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1.  Primary:   Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit   [ Time Frame: Baseline and 6 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 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: Mark Lavigne
Organization: Halyard Health, Inc.
phone: 508-837-1427
e-mail: mark.lavigne@hyh.com



Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT01263054     History of Changes
Other Study ID Numbers: 100-10-0001
Study First Received: November 29, 2010
Results First Received: January 13, 2016
Last Updated: February 11, 2016
Health Authority: United States: Institutional Review Board