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Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

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ClinicalTrials.gov Identifier: NCT01156675
Recruitment Status : Terminated
First Posted : July 5, 2010
Results First Posted : April 27, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Globus Medical Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Lumbar Spinal Stenosis
Interventions: Device: FLEXUS(TM) Interspinous Spacer
Device: XSTOP® Interspinous Spacer

  Participant Flow

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
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Reporting Groups
  Description
FLEXUS™ Interspinous Spacer FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the XSTOP® Spacer
No Treatment Not treated with FLEXUS or X-STOP

Participant Flow:   Overall Study
    FLEXUS™ Interspinous Spacer   X-STOP® Interspinous Spacer   No Treatment
STARTED   107   106   2 
COMPLETED   73   81   0 
NOT COMPLETED   34   25   2 
Death                5                3                0 
No data                29                22                2 



  Baseline Characteristics

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.
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Reporting Groups
  Description
FLEXUS™ Interspinous Spacer FLEXUS(TM) Interspinous Spacer: Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
X-STOP® Interspinous Spacer X-STOP® Interspinous Spacer: Treatment of lumbar spinal stenosis with the X-STOP® Spacer
No Treatment Not treated with FLEXUS or X-STOP
Total Total of all reporting groups

Baseline Measures
   FLEXUS™ Interspinous Spacer   X-STOP® Interspinous Spacer   No Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   106   2   215 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.2  (8.93)   67.3  (8.88)   71.5  (4.95)   67.8  (8.87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      54  50.5%      46  43.4%      1  50.0%      101  47.0% 
Male      53  49.5%      60  56.6%      1  50.0%      114  53.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Race         
Caucasian      98  91.6%      102  96.2%      2 100.0%      202  94.0% 
Black      7   6.5%      3   2.8%      0   0.0%      10   4.7% 
Asian      1   0.9%      0   0.0%      0   0.0%      1   0.5% 
Hispanic      1   0.9%      0   0.0%      0   0.0%      1   0.5% 
Other      0   0.0%      1   0.9%      0   0.0%      1   0.5% 
Weight (lbs) 
[Units: Lbs]
Mean (Standard Deviation)
 181.8  (33.87)   193.2  (37.75)   195.0  (77.78)   187.5  (36.45) 
Height (inches) 
[Units: Inches]
Mean (Standard Deviation)
 67.0  (3.62)   67.2  (3.94)   66.0  (11.31)   67.1  (3.84) 


  Outcome Measures

1.  Primary:   Number of Participants With Less Pain/Disability Using the Zurich Claudication Questionnaire (ZCQ) Score   [ Time Frame: 24 months ]

2.  Primary:   Number of Participants With a Successful Neurologic Status   [ Time Frame: 24 months ]

3.  Primary:   Number of Participants With no Additional Surgery for Lumbar Spinal Stenosis at the Spinal Level That Was Treated   [ Time Frame: 24 months ]

4.  Primary:   Number of Participants With an Absence of Implant-related Complications   [ Time Frame: 24 months ]

5.  Secondary:   Mean Oswestry Disability Index (ODI) at 24 Months   [ Time Frame: 24 months ]

6.  Secondary:   Mean Visual Analog Scale (VAS) - Back Pain at 24 Months   [ Time Frame: 24 months ]

7.  Secondary:   Mean Visual Analog Scale (VAS) - Right Leg Pain at 24 Months   [ Time Frame: 24 months ]

8.  Secondary:   Mean Visual Analog Scale (VAS) - Left Leg Pain at 24 Months   [ Time Frame: 24 months ]

9.  Secondary:   Change of Quality of Life   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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: Director, Clinical Affairs
Organization: Globus Medical
phone: 610-930-1800 ext 1669
e-mail: jmyer@globusmedical.com



Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01156675     History of Changes
Other Study ID Numbers: GPR003
First Submitted: July 1, 2010
First Posted: July 5, 2010
Results First Submitted: December 13, 2017
Results First Posted: April 27, 2018
Last Update Posted: June 1, 2018