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CAFE Study - Cancer Patient Fracture Evaluation (CAFE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211237
First Posted: September 21, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Spine LLC
Results First Submitted: March 31, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Of 134 enrolled subjects, 70 were randomized to Balloon Kyphoplasty and 64 to non-surgical management (NSM). Two of the subjects who were randomized to Balloon Kyphoplasty and 3 of the subjects who were randomized to NSM were excluded from the mITT and PP Populations, because they terminated in a few days of enrolment and had no treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Crossover from the NSM group to Balloon Kyphoplasty group was permitted after completion of the 1-month evaluation.

Reporting Groups
  Description
Balloon Kyphoplasty The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
Non-surgical Management The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
Crossover Subjects in this group were randomized to NSM, then, crossed over to Balloon Kyphoplasty after completion of the 1-month evaluation in NSM group.

Participant Flow for 5 periods

Period 1:   Baseline
    Balloon Kyphoplasty   Non-surgical Management   Crossover
STARTED   70   64   0 
COMPLETED   68   61   0 
NOT COMPLETED   2   3   0 
Withdrew                1                3                0 
Refused random assignment                1                0                0 

Period 2:   1 Month
    Balloon Kyphoplasty   Non-surgical Management   Crossover
STARTED   68   61   0 
COMPLETED   65   52   0 
NOT COMPLETED   3   9   0 
Death                2                1                0 
Lost to Follow-up                0                2                0 
Withdrew                0                4                0 
Additional surgery needed                1                0                0 
Non-medical problem                0                2                0 

Period 3:   3 Months
    Balloon Kyphoplasty   Non-surgical Management   Crossover
STARTED   65   18 [1]   34 
COMPLETED   57   14   33 
NOT COMPLETED   8   4   1 
Death                7                3                0 
Could not comply with protocol                1                0                0 
Withdrew                0                1                0 
Non-medical problem                0                0                1 
[1] 34 patients crossed over to Balloon Kyphoplasty.

Period 4:   6 Months
    Balloon Kyphoplasty   Non-surgical Management   Crossover
STARTED   57   11 [1]   36 
COMPLETED   49   9   33 
NOT COMPLETED   8   2   3 
Death                6                0                3 
Lost to Follow-up                2                0                0 
Could not comply with protocol                0                2                0 
[1] 3 patients crossed over Balloon Kyphoplasty

Period 5:   12 Months
    Balloon Kyphoplasty   Non-surgical Management   Crossover
STARTED   49   8 [1]   34 
COMPLETED   40   6   28 
NOT COMPLETED   9   2   6 
Death                8                2                3 
Lost to Follow-up                1                0                1 
Withdrew                0                0                1 
unrelated medical problem                0                0                1 
[1] 1 patient crossed over Balloon Kyphoplasty



  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 The subjects assigned to this group have undergone the treatment with Balloon Kyphoplasty for their painful VCFs.
Non Surgical Management The subjects in this group have undergone the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.
Total Total of all reporting groups

Baseline Measures
   Balloon Kyphoplasty   Non Surgical Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 70   64   134 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.8  (10.8)   63.0  (11.4)   63.9  (11.0) 
Sex/Gender, Customized 
[Units: Participants]
     
Male   28   26   54 
Female   40   35   75 
Missing   2   3   5 


  Outcome Measures
  Show All 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:   Change in Roland-Morris Disability Questionnaire Score   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

3.  Secondary:   Change in Functional Status Assessed With the Karnofsky Performance Scale   [ Time Frame: Baseline and 1 month ]

4.  Secondary:   Change in Functional Status Assessed With the Karnofsky Performance Scale   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

5.  Secondary:   Change in Back Pain   [ Time Frame: Baseline and 1 month ]

6.  Secondary:   Change in Back Pain   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

7.  Secondary:   Change in Quality of Life.   [ Time Frame: Baseline and 1 month ]

8.  Secondary:   Change in Quality of Life   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

9.  Secondary:   Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline and 1 month ]

10.  Secondary:   Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

11.  Secondary:   Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline and 1 month ]

12.  Secondary:   Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

13.  Secondary:   Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline and 1 month ]

14.  Secondary:   Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks   [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ]

15.  Secondary:   Ambulatory Status Change From Baseline to One Month   [ Time Frame: 1 month ]

16.  Secondary:   Ambulatory Status Change   [ Time Frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months ]

17.  Secondary:   Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month   [ Time Frame: Baseline and 1 month ]

18.  Secondary:   Index Spinal Deformity Change Measured by Index Vertebral Body Angles   [ Time Frame: Baseline, post-operation, 1 month, and 12 months ]

19.  Secondary:   Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio   [ Time Frame: Baseline and 1 month ]

20.  Secondary:   Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio   [ Time Frame: Baseline, post-operation, 1 month, and 12 months ]

21.  Secondary:   Back Pain Analgesics Used   [ Time Frame: Baseline, 7 days, and 1 month ]

22.  Secondary:   Back Pain Analgesics Used   [ Time Frame: Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months ]

23.  Secondary:   Change in Neurology Status From Baseline (Motor Strength)   [ Time Frame: 1 month ]

24.  Secondary:   Change in Neurology Status From Baseline (Motor Strength)-Per Protocol   [ Time Frame: 1 month, 3 months, 6 months, and 12 months ]

25.  Secondary:   Change in Neurological Status From Baseline (Sensory Examination)   [ Time Frame: 1 month ]

26.  Secondary:   Change in Neurological Status From Baseline (Sensory Examination)   [ Time Frame: 1 months, 3 months, 6 months, and 12 months ]

27.  Secondary:   Change in Neurological Status From Baseline (Reflex Strength)   [ Time Frame: 1 month ]

28.  Secondary:   Change in Neurological Status From Baseline (Reflex Strength)   [ Time Frame: 1 months, 3 months, 6 months, and 12 months ]

29.  Secondary:   Change in Neurological Status From Baseline (Limb Strength)   [ Time Frame: 1 month ]

30.  Secondary:   Change in Neurological Status From Baseline (Limb Strength)   [ Time Frame: 1 months, 3 months, 6 months, and 12 months ]

31.  Secondary:   Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline   [ Time Frame: 1 month ]

32.  Secondary:   Rate of Study Treatment-related Adverse Events Till Study Completion   [ Time Frame: 12 months ]

33.  Secondary:   Rate of Subsequent Vertebral Body Fractures   [ Time Frame: 1 month ]

34.  Secondary:   Rate of Subsequent Vertebral Body Fractures   [ Time Frame: 1 month and 12 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
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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00211237     History of Changes
Other Study ID Numbers: SP0401 - CAFE Study
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: March 31, 2010
Results First Posted: May 14, 2010
Last Update Posted: October 12, 2017