Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medtronic Spine LLC |
---|---|
Information provided by: | Medtronic Spine LLC |
ClinicalTrials.gov Identifier: | NCT00211211 |
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
Condition | Intervention | Phase |
---|---|---|
Osteopenia Osteoporosis Multiple Myeloma Bone Neoplasms |
Device: Balloon Kyphoplasty |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures |
Estimated Enrollment: | 300 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | December 2007 |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-existing conditions contrary to the kyphoplasty procedure:
Study ID Numbers: | SP0201 - FREE Study |
Study First Received: | September 13, 2005 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00211211 |
Health Authority: | United States: Institutional Review Board |
Osteopenia Osteoporosis Multiple Myeloma Osteolytic Metastatic Tumors |
Vertebral Compression Fracture Back Pain Spine |
Fractures, Compression Bone Neoplasms Blood Protein Disorders Fractures, Bone Bone neoplasms Disorders of Environmental Origin Pain Paraproteinemias Hemostatic Disorders Bone Diseases Hemorrhagic Disorders Musculoskeletal Diseases Multiple myeloma |
Neoplasm Metastasis Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Wounds and Injuries Osteoporosis Bone Diseases, Metabolic Back Pain Multiple Myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immune System Diseases Cardiovascular Diseases |