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A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

This study has been terminated.
(Study terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT00697827
First received: June 11, 2008
Last updated: June 5, 2012
Last verified: June 2012
Results First Received: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Spinal Stenosis
Interventions: Device: Interspinous Spacer device
Device: Interspinous Process Distraction Device

  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
In-Space The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
X-Stop The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.

Participant Flow:   Overall Study
    In-Space     X-Stop  
STARTED     28     16  
COMPLETED     26     15  
NOT COMPLETED     2     1  
enrolled but not treated                 2                 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
In-Space The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5.
X-Stop The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels.
Total Total of all reporting groups

Baseline Measures
    In-Space     X-Stop     Total  
Number of Participants  
[units: participants]
  28     16     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     7     23  
>=65 years     12     9     21  
Age  
[units: years]
Mean ± Standard Deviation
  63.1  ± 7.88     64.8  ± 6.69     64.0  ± 7.23  
Gender  
[units: participants]
     
Female     18     7     25  
Male     10     9     19  
Region of Enrollment  
[units: participants]
     
United States     28     16     44  



  Outcome Measures
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1.  Primary:   Zurich Claudication Questionnaire(ZCQ)   [ Time Frame: 24 months ]

2.  Secondary:   Oswestry Disability Index (ODI)   [ 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
Study terminated early secondary to low enrollment leading to small number of subjects available for analyses.


  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: Ann Marie Simon
Organization: Synthes
phone: 610-719-5418
e-mail: simon.annmarie@synthes.com


No publications provided


Responsible Party: Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier: NCT00697827     History of Changes
Other Study ID Numbers: INSP01
Study First Received: June 11, 2008
Results First Received: May 3, 2012
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration