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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00211237
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
5/01/2021

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
Timepoint [1] 0 0
Baseline and 1 Month
Secondary outcome [1] 0 0
Change in Roland-Morris Disability Questionnaire Score
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
Timepoint [2] 0 0
Baseline and 1 month
Secondary outcome [3] 0 0
Change in Functional Status Assessed With the Karnofsky Performance Scale
Timepoint [3] 0 0
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary outcome [4] 0 0
Change in Back Pain
Timepoint [4] 0 0
Baseline and 1 month
Secondary outcome [5] 0 0
Change in Back 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.
Timepoint [6] 0 0
Baseline and 1 month
Secondary outcome [7] 0 0
Change in 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
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
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
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
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
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
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
Timepoint [14] 0 0
1 month
Secondary outcome [15] 0 0
Ambulatory Status Change
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
Timepoint [16] 0 0
Baseline and 1 month
Secondary outcome [17] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Angles
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
Timepoint [18] 0 0
Baseline and 1 month
Secondary outcome [19] 0 0
Index Spinal Deformity Change Measured by Index Vertebral Body Height Ratio
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)
Timepoint [22] 0 0
1 month
Secondary outcome [23] 0 0
Change in Neurology Status From Baseline (Motor Strength)-Per Protocol
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)
Timepoint [24] 0 0
1 month
Secondary outcome [25] 0 0
Change in Neurological Status From Baseline (Sensory Examination)
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)
Timepoint [26] 0 0
1 month
Secondary outcome [27] 0 0
Change in Neurological Status From Baseline (Reflex Strength)
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)
Timepoint [28] 0 0
1 month
Secondary outcome [29] 0 0
Change in Neurological Status From Baseline (Limb Strength)
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
Timepoint [30] 0 0
1 month
Secondary outcome [31] 0 0
Rate of Study Treatment-related Adverse Events Till Study Completion
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
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
Sex
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
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
134
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00211237