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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00211237




Registration number
NCT00211237
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
8/12/2017

Titles & IDs
Public title
CAFE Study - Cancer Patient Fracture Evaluation
Scientific title
A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients
Secondary ID [1] 0 0
SP0401 - CAFE Study
Universal Trial Number (UTN)
Trial acronym
CAFE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Spinal Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Balloon Kyphoplasty
Other interventions - Non Surgical Management

Experimental: Balloon Kyphoplasty (BKP) - The subjects assigned to this group will undergo the treatment with Balloon kyphoplasty for their painful VCFs.

Active Comparator: Non Surgical Management - The subjects in this group will undergo the non-operative treatments aimed at alleviation of back pain and restoration of decreased function associated with VCFs.


Treatment: Devices: Balloon Kyphoplasty
Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.

Other interventions: Non Surgical Management
Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Functional Status, as Measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 Month - The full scale name is the Roland-Morris Disability Questionnaire; it is a validated measure of physical disability due to back pain.
The best score is 0 (no disability) and worst is 24 (maximum disability)
Timepoint [1] 0 0
Baseline and 1 Month
Secondary outcome [1] 0 0
Change in Roland-Morris Disability Questionnaire Score - Roland-Morris Disability Questionnaire (RMDQ) was used to assess the physical disability due to back pain. The best score is 0 (no disability) and worst is 24 (maximum disability).
Timepoint [1] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [2] 0 0
Change in Functional Status Assessed With the Karnofsky Performance Scale - The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Timepoint [2] 0 0
Baseline and 1 month
Secondary outcome [3] 0 0
Change in Functional Status Assessed With the Karnofsky Performance Scale - The Karnofsky Performance Scale rates a patient on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease).
Timepoint [3] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [4] 0 0
Change in Back Pain - Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).
Timepoint [4] 0 0
Baseline and 1 month
Secondary outcome [5] 0 0
Change in Back Pain - Back pain was assessed on a NRS from 0 (no pain) to 10 (worst possible pain).
Timepoint [5] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [6] 0 0
Change in Quality of Life. - The SF-36 was used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Timepoint [6] 0 0
Baseline and 1 month
Secondary outcome [7] 0 0
Change in Quality of Life - The SF-36 were used to assess quality of life. The SF-36 results were summarized into two components, a physical component summary score (PCS) (0-100) and a mental component summary score (MCS) (0-100). The higher the score, the better the quality of life.
Timepoint [7] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [8] 0 0
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [8] 0 0
Baseline and 1 month
Secondary outcome [9] 0 0
Change in Activities of Daily Living - Activities Reduced Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [9] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [10] 0 0
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [10] 0 0
Baseline and 1 month
Secondary outcome [11] 0 0
Change in Activities of Daily Living - Number of Days With Reduced Activities Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [11] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [12] 0 0
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [12] 0 0
Baseline and 1 month
Secondary outcome [13] 0 0
Change in Activities of Daily Living - Number of Days in Bed Due to Back Pain in Previous 2 Weeks - The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems.
Timepoint [13] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [14] 0 0
Ambulatory Status Change From Baseline to One Month - Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Timepoint [14] 0 0
1 month
Secondary outcome [15] 0 0
Ambulatory Status Change - Ambulatory status was assessed using a three-category system, fully ambulatory, ambulatory with assistance, or not ambulatory.
Timepoint [15] 0 0
Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [16] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Angles From Baseline to 1 Month - Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Timepoint [16] 0 0
Baseline and 1 month
Secondary outcome [17] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Angles - Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF.
Timepoint [17] 0 0
Baseline, post-operation, 1 month, and 12 months
Secondary outcome [18] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio - Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Timepoint [18] 0 0
Baseline and 1 month
Secondary outcome [19] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio - Index spinal deformity was measured by Kyphotic angle, local Cobb angle, thoracic and lumbar Cobb angle, and anterior, middle and posterior vertebral body heights for each index VCF. Index Vertebral Body Height Ratio (VBHR) was defined as index vertebra height divided by the average of normal superior and inferior adjacent vertebrae.
Timepoint [19] 0 0
Baseline, post-operation, 1 month, and 12 months
Secondary outcome [20] 0 0
Back Pain Analgesics Used
Timepoint [20] 0 0
Baseline, 7 days, and 1 month
Secondary outcome [21] 0 0
Back Pain Analgesics Used
Timepoint [21] 0 0
Baseline, 7 days, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [22] 0 0
Change in Neurology Status From Baseline (Motor Strength) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Timepoint [22] 0 0
1 month
Secondary outcome [23] 0 0
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of motor strength (scored 0-5) for rectus abdominis, hip extensors and flexors, knee extensors and flexors, and foot plantar and dorsiflexors as following:
absent voluntary contraction = 0, contractions unable to move joint = 1, movement with gravity eliminated = 2, movement against gravity = 3, movement against resistance = 4, full strength = 5
Timepoint [23] 0 0
1 month, 3 months, 6 months, and 12 months
Secondary outcome [24] 0 0
Change in Neurological Status From Baseline (Sensory Examination) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Timepoint [24] 0 0
1 month
Secondary outcome [25] 0 0
Change in Neurological Status From Baseline (Sensory Examination) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. For sensory examination, the Investigator assessed sensory status at baseline and a change from baseline beginning with the most cephalad index level treated through L5.
Timepoint [25] 0 0
1 months, 3 months, 6 months, and 12 months
Secondary outcome [26] 0 0
Change in Neurological Status From Baseline (Reflex Strength) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Timepoint [26] 0 0
1 month
Secondary outcome [27] 0 0
Change in Neurological Status From Baseline (Reflex Strength) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Evaluation criteria of reflexes (scored 0-3) for patellar and Achilles reflexes as following:
absent = 0, hypoactive = 1, normal = 2, brisk or clonus = 3
Timepoint [27] 0 0
1 months, 3 months, 6 months, and 12 months
Secondary outcome [28] 0 0
Change in Neurological Status From Baseline (Limb Strength) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Timepoint [28] 0 0
1 month
Secondary outcome [29] 0 0
Change in Neurological Status From Baseline (Limb Strength) - The neurological examination included motor strength, sensory examination, reflexes below the level of the most cephalad index vertebral body fracture, and the presence of radicular pain. Radicular lower limb pain was assessed the presence of paresthesia, weakness, and/or painful straight leg raising (SLR).
Timepoint [29] 0 0
1 months, 3 months, 6 months, and 12 months
Secondary outcome [30] 0 0
Rate of Study Treatment-related Adverse Events Within 30 Days of Baseline - The study treatment-related AEs were defined as follows:
Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Timepoint [30] 0 0
1 month
Secondary outcome [31] 0 0
Rate of Study Treatment-related Adverse Events Till Study Completion - The study treatment-related AEs were defined as follows:
Related defined as the AE had a direct relationship to a Sponsor medical device used in the study patient.
Possibly related defined as the AE may have had a relationship to a Sponsor medical device but an alternative cause may be equally or less likely associated.
Unrelated defined as the AE was due to the underlying indication or disease state or to concomitant medication or therapy not related to any Sponsor device.
Unknown defined as the relationship of the AE to a Sponsor device could not be determined.
Timepoint [31] 0 0
12 months
Secondary outcome [32] 0 0
Rate of Subsequent Vertebral Body Fractures
Timepoint [32] 0 0
1 month
Secondary outcome [33] 0 0
Rate of Subsequent Vertebral Body Fractures - Based on patients with at least 7 analyzable vertebrae.
Timepoint [33] 0 0
1 month and 12 months

Eligibility
Key inclusion criteria
1. One to 3 painful (pain on palpation/percussion over fractured vertebral body) VCF(s),
T5-L5, with either bone marrow edema imaged by magnetic resonance imaging (MRI) or a
fracture imaged by plain radiographs using the method of Genant

2. Pain NRS score =4 on a scale of 0 to 10

- When the patient is newly diagnosed with multiple myeloma, the pain assessment
must not be done until after completion of at least one pulse of steroid therapy
or one week after the initiation of active multiple myeloma therapy.

3. Roland Morris Disability Questionnaire score = 10 on a scale of 0 to 24

4. Patients must be at least 21 years old.

5. No change in chemotherapy regimen (change in dose(s) permitted) for 1 month prior to
enrollment

6. No change in chemotherapy regimen (change in dose(s) permitted) planned for at least 1
month following enrollment

7. No major surgery to the spine planned for at least 1 month following enrollment

8. Life expectancy of = 3 months

9. Patient has sufficient mental capacity to comply with the protocol requirements

10. Patient has stated availability for all study visits

11. Patient is able to understand the risks and benefits of participating in the study and
is willing to provide written informed consent.
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma
at site of the index VCF. Patients with these tumors in anatomic sites other than the
index VCF are eligible.

2. Concurrent Phase I investigational anti-cancer treatment

3. Significant clinical morbidities (aside from the index fracture(s) and cancer) that
may potentially interfere with the collection of data concerning pain and function

4. VCF morphology deemed unsuitable for balloon kyphoplasty

5. Additional non-kyphoplasty surgical treatment is required for the index fracture

6. Patients requiring the use of high-dose steroid (= 100 mg prednisone or 20 mg
dexamethasone per day), intravenous (IV) pain medication, or nerve block to control
chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids
for treatment of their cancer (for at least 30 days) are eligible.

7. Patients with a platelet count of < 20,000 measured at the time of hospital admission
for the procedure

8. Spinal cord compression or canal compromise requiring decompression

9. Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic
tumors outside of vertebral levels intended for kyphoplasty may be enrolled.

10. Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in
the presence of active or incompletely treated local infection)

11. Known allergy to bone cement or contrast medium used in the treatment of study
subjects

12. MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted
biostimulators, cochlear implants, penile prosthesis)

13. Positive baseline pregnancy test (for women of child-bearing potential)

14. Patients who may require allogeneic bone marrow transplantation during the course of
the study.

Other Reasons for Lack of Enrollment:

A. Patient is afraid to have surgery

B. Patient is afraid to have anesthesia

C. Patient/family is not willing to participate in research

D. Patient is not willing to be randomized

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
Belgium
State/province [9] 0 0
Brussels
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Sweden
State/province [16] 0 0
Uppsala
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Spine LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the safety and effectiveness of balloon
kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared
to standard non-surgical therapy in patients with cancer.
Trial website
https://clinicaltrials.gov/show/NCT00211237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Berenson, M.D.
Address 0 0
Institute for Myeloma & Bone Cancer Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications