Condition of Approval Study (COAST)

This study has been terminated.
(Due to Medtronic's voluntary withdrawal of PMA P040001 for X-STOP systems; post-approval study costs outweighed business benefits for marketing X-STOP in US.)
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00517751
First received: August 15, 2007
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lumbar Spinal Stenosis
Intervention: Device: X-STOP PEEK

  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
Due to early study termination, the final analysis is consistent with the last annual report submission to the FDA and data reported on FDA’s post-approval webpage reporting on 162 of 176 enrolled subjects.

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
X-STOP PEEK In this arm, patients underwent X-STOP PEEK surgery.

Participant Flow:   Overall Study
    X-STOP PEEK  
STARTED     162  
COMPLETED     33  
NOT COMPLETED     129  
Death                 3  
Withdrawal by Subject                 37  
Lost to Follow-up                 4  
patient not over due                 6  
Patient not due for visit                 76  
Missing                 3  



  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
X-STOP PEEK In this arm, patients underwent X-STOP PEEK surgery.

Baseline Measures
    X-STOP PEEK  
Number of Participants  
[units: participants]
  162  
Age  
[units: years]
Mean (Standard Deviation)
  71.5  (8.40)  
Gender  
[units: participants]
 
Female     75  
Male     87  
Race/Ethnicity, Customized  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Black or African American     4  
Hispanic or Latino     4  
Native Hawaiian or other pacific islander     1  
Caucasian     152  
Other     0  
Height  
[units: inches]
Mean (Standard Deviation)
  67.2  (3.93)  
Weight  
[units: lbs]
Mean (Standard Deviation)
  188.0  (37.40)  
Body Mass Index  
[units: kg/m^2]
Mean (Standard Deviation)
  29.3  (4.72)  



  Outcome Measures
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1.  Primary:   Treatment Success Rate at 24 Months   [ Time Frame: 24 months ]

2.  Secondary:   Treatment Success Rate at 60 Months   [ Time Frame: 60 months ]

3.  Secondary:   Symptom Severity (SS) Scores Measured by Zurich Claudication Questionnaire (ZCQ)   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

4.  Secondary:   Success Rate in Symptom Severity (SS) Domain of Zurich Claudication Questionnaire (ZCQ)   [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ]

5.  Secondary:   Physical Function (PF) Scores Measured by Zurich Claudication Questionnaire (ZCQ)   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

6.  Secondary:   Success Rate in Physical Function (PF) Domain of Zurich Claudication Questionnaire (ZCQ)   [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ]

7.  Secondary:   Patient Satisfaction (PS) Scores Measured by Zurich Claudication Questionnaire (ZCQ) at Post Treatment   [ Time Frame: 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

8.  Secondary:   Success Rate in Patient Satisfaction (PS) Domain of Zurich Claudication Questionnaire (ZCQ) at Post Treatment   [ Time Frame: 6 weeks, 12months, 24 months, 36 months, 48 months, and 60 months ]

9.  Secondary:   Oswestry Disability Index (ODI) Score   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

10.  Secondary:   General Health Status -- SF-36 PCS   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

11.  Secondary:   General Health Status -- SF-36 MCS   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

12.  Secondary:   Back Pain in Numerical Rating Scales (NRS)   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

13.  Secondary:   Left Leg Pain in Numerical Rating Scales (NRS)   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

14.  Secondary:   Right Leg Pain in Numerical Rating Scales (NRS)   [ Time Frame: Baseline, 6 weeks, 12 months, 24 months, 36 months, 48 months, and 60 months ]

15.  Other Pre-specified:   Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 24 Months   [ Time Frame: 24 months ]

16.  Other Pre-specified:   Percent of Subjects With Pfirrmann Grades Increased From Baseline at Any Index Level at 60 Months   [ Time Frame: 60 months ]

17.  Other Pre-specified:   Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 24 Months   [ Time Frame: 24 months ]

18.  Other Pre-specified:   Percent of Subjects With Pfirrmann Grades Increased at Adjacent Levels at 60 Months   [ Time Frame: 60 months ]

19.  Other Pre-specified:   Percent of Subjects Who Reported Implant-Related Adverse Events   [ Time Frame: Overall study period ]

20.  Other Pre-specified:   Percent of Subjects Who Had Any Subsequent Lumbar Spine Surgery   [ Time Frame: Overall study period ]


  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 strengths include collection of 5-year data and radiographic examinations. Study weaknesses include single-arm design and early termination of the study without reaching the desired sample size.


  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


Publications:

Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00517751     History of Changes
Other Study ID Numbers: LSS-006-COA
Study First Received: August 15, 2007
Results First Received: December 1, 2015
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration