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CAFE Study - Cancer Patient Fracture Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00211237
First received: September 13, 2005
Last updated: February 16, 2012
Last verified: May 2010
Results First Received: March 31, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Spinal Fractures
Interventions: Device: Balloon Kyphoplasty
Other: Non Surgical 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
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
Balloon Kyphoplasty Randomized, Unblinded Controlled Study
Non Surgical Management Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).

Participant Flow:   Overall Study
    Balloon Kyphoplasty     Non Surgical Management  
STARTED     70     64  
COMPLETED     40     34  
NOT COMPLETED     30     30  
Death                 23                 12  
Lost to Follow-up                 2                 2  
Withdrawal by Subject                 5                 14  
Physician Decision                 0                 2  



  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
Balloon Kyphoplasty Randomized, Unblinded Controlled Study
Non Surgical Management Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
Total Total of all reporting groups

Baseline Measures
    Balloon Kyphoplasty     Non Surgical Management     Total  
Number of Participants  
[units: participants]
  70     64     134  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 10.8     63.0  ± 11.4     63.9  ± 11.0  
Gender, Customized  
[units: participants]
     
Male     28     26     54  
Female     40     35     75  
Missing     2     3     5  



  Outcome Measures

1.  Primary:   The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month   [ Time Frame: Baseline and 1 Month ]

2.  Secondary:   Study Treatment-related Adverse Events and Change in Neurological Status   [ Time Frame: Baseline, 1 Month , 3 Month, 6 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Clinical: Change in Functional Status (as Assessed With the Roland-Morris Disability Questionnaire and the Karnofsky Performance Scale)   [ Time Frame: Baseline, 1 Month , 3 Month, 6 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Quality of Life (as Assessed by the SF-36v2™ Health Survey)   [ Time Frame: Baseline, 1 Month, 3 Month, 6 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Back Pain (as Measured by a 10-point Numerical Rating Scale)   [ Time Frame: Baseline, 7-10 Day Phone Call, 1 Month, 3 Month, 6 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Radiographic: Change in Spinal Deformity, Defined as the Degree of Spine Angulation (as Assessed by an Independent Radiologist at the Core Laboratory)   [ Time Frame: Baseline, Pre-op, Post-Op, 1 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Radiographic: Rate of Subsequent Vertebral Body Fractures (as Assessed by Independent Radiologists at the Core Laboratory)   [ Time Frame: Baseline, Pre-op, Post-Op, 1 Month and 12 Month ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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: zhimin Liu
Organization: Medtronic Spine LLC
phone: 901-399-3123
e-mail: zhimin.liu@medtronic.com


No publications provided by Medtronic Spine LLC

Publications automatically indexed to this study:

Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00211237     History of Changes
Other Study ID Numbers: SP0401 - CAFE Study
Study First Received: September 13, 2005
Results First Received: March 31, 2010
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board