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Sponsored by: |
Medtronic Spine LLC |
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Information provided by: | Medtronic Spine LLC |
ClinicalTrials.gov Identifier: | NCT00211237 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer Spinal Fractures |
Device: Balloon Kyphoplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official 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 |
Estimated Enrollment: | 200 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
1. STUDY OBJECTIVES AND ENDPOINTS
1.1. Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.
1.2. Primary Endpoint
The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.
1.3. Secondary Endpoints
The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.
Safety:
Clinical:
Change in functional status as assessed with
Radiographic:
In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pain NRS score > 4 on a scale of 0 to 10
Exclusion Criteria:
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
United States, California | |
Valley Radiology Inc., UCSD | |
Escondido, California, United States, 92025 | |
United States, Colorado | |
Boulder Neurosurgical Associates | |
Boulder, Colorado, United States, 80304 | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Maryland | |
Sibley Memorial Hospital | |
Chevy Chase, Maryland, United States, 20815 | |
Greater Oncology Associates | |
Silver Spring, Maryland, United States, 20910 | |
United States, Michigan | |
Karmanos Cancer Center | |
Detroit, Michigan, United States, 48201 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 | |
Australia, Victoria | |
St. Vincent's Hospital | |
Fitzroy, Victoria, Australia, 3065 | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Canada, Alberta | |
Foothills Hospital | |
Calgary, Alberta, Canada, T2N2T9 | |
Canada, Ontario | |
Toronto Western Hospital | |
Toronto, Ontario, Canada, M5T 2S8 | |
Canada, Quebec | |
Montreal General Hospital | |
Montreal, Quebec, Canada, H3G 1A4 |
Principal Investigator: | James Berenson, M.D. | Institute for Myeloma & Bone Cancer Research |
Principal Investigator: | Frank Vrionis, M.D. | H. Lee Moffitt Cancer Center |
Responsible Party: | Medtronic Spine LLC ( Van Weiss / Sr. Clinical Research Manager ) |
Study ID Numbers: | SP0401 - CAFE Study |
Study First Received: | September 13, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00211237 |
Health Authority: | United States: Institutional Review Board |
Balloon Kyphoplasty Cancer Vertebral Compression Fracture Back Pain Spine |
Fractures, Compression Spinal Injuries Fractures, Bone Back Injuries Wounds and Injuries |
Spinal Fractures Disorders of Environmental Origin Pain Back Pain |