INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine (TLIF)

This study has been terminated.
(Due to study design challenges including DMC enrollment suspension as required by the protocol stopping rules and recommended changes to the surgical technique)
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT01415908
First received: August 10, 2011
Last updated: September 25, 2015
Last verified: September 2015
Results First Received: September 25, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lumbar Spine Degeneration
Interventions: Device: INFUSE Bone Graft
Other: Iliac Crest Bone Graft

  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
No text entered.

Reporting Groups
  Description
Investigational Group Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
Control Group Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.

Participant Flow:   Overall Study
    Investigational Group     Control Group  
STARTED     11     4  
COMPLETED     10     4  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  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
Investigational Group Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
Control Group Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
Total Total of all reporting groups

Baseline Measures
    Investigational Group     Control Group     Total  
Number of Participants  
[units: participants]
  11     4     15  
Age  
[units: years]
Mean (Standard Deviation)
  50.5  (11.88)     56.2  (12.26)     52.0  (11.83)  
Gender  
[units: participants]
     
Female     5     2     7  
Male     6     2     8  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     9     4     13  
Black     0     0     0  
Asian     2     0     2  
Hispanic     0     0     0  
Other     0     0     0  
Height  
[units: Inches]
Mean (Standard Deviation)
  67.6  (3.35)     68.5  (3.87)     67.9  (3.38)  
Weight  
[units: lbs]
Mean (Standard Deviation)
  179.7  (37.25)     183.5  (38.10)     180.7  (36.13)  



  Outcome Measures
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1.  Primary:   Rate of Overall Success   [ Time Frame: 24 months ]

2.  Secondary:   Rate of Fusion Success   [ Time Frame: 24 months ]

3.  Secondary:   Success Rate of Oswestry Disability Index   [ Time Frame: 24 months ]

4.  Secondary:   Success Rate of Neurological Status   [ Time Frame: 24 months ]

5.  Secondary:   Success Rate of Back Pain   [ Time Frame: 24 months ]

6.  Secondary:   Success Rate of Leg Pain   [ Time Frame: 24 months ]

7.  Secondary:   Success Rate of General Health Status   [ Time Frame: 24 months ]

8.  Secondary:   Percent of Subjects Who Had Additional Surgical Procedures/Interventions   [ Time Frame: 24 months ]

9.  Secondary:   Operative Time   [ Time Frame: Operative time was recorded from skin incision to wound closure ]

10.  Secondary:   Blood Loss   [ Time Frame: During the operation ]

11.  Secondary:   Hospital Stay   [ Time Frame: During the time of hospital stay ]


  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
A total of 534 ± 10 subjects were planned for enrollment. However, this study was terminated early with only 15 enrolled patients, leading to small numbers of subjects analyzed.


  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: Clinical Department
Organization: Medtronic Spinal and Biologics
phone: 1800-876-3133 ext 6068
e-mail: msbkclinicalresearch@medtronic.com


No publications provided


Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01415908     History of Changes
Other Study ID Numbers: Medtronic P05-06
Study First Received: August 10, 2011
Results First Received: September 25, 2015
Last Updated: September 25, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board