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ClinicalTrials.gov Identifier: NCT00211211
: September 21, 2005
Last Update Posted
: December 8, 2017
Medtronic Spine LLC
Information provided by (Responsible Party):
Medtronic Spinal and Biologics ( Medtronic Spine LLC )
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.
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
Study Start Date
Primary Completion Date
Study Completion Date
Resource links provided by the National Library of Medicine
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 compression fractures (VCFs).
Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
The primary study endpoint is the change in quality of life as measured by the Physical Component Summary (PCS) scale of the 36-Item Short Form (SF-36) as measured at the one-month follow-up visit.
Secondary Outcome Measures
The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Minimum of one painful, acute (edema present on MRI obtained within a two weeks period prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (NOTE: a T2-weighted MRI should be done unless it is not available);
Minimum of one acute fracture to be treated that has height loss > 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from Black et al.)
Pre-treatment VAS score > 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine";
Patient 21 years of age or older;
The investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and
A signed Informed Consent is obtained from the patient.
Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles);
Acute fracture(s) to be treated symptomatic > 3 months at enrollment;
Pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable;
Spinal cord compression or canal compromise requiring decompression;
Disabling back pain secondary to causes other than acute fracture;
Vertebral fracture due to primary or osteoblastic tumors;
Patient is currently on anticoagulation therapy that can not be interrupted;
Pre-existing conditions contrary to the kyphoplasty procedure:
Local fractured vertebral body infection
Temporarily non-reversible bleeding disorder
Known allergy to any of the drugs, bone void filler material or contrast medium used in the treatment of study subjects
Dementia and/or inability to give informed consent;
Inability to walk or stand prior to the vertebral body fracture (walking aids are allowed);
Neoplasms, Plasma Cell
Bone Diseases, Metabolic
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Wounds and Injuries
Neoplasms by Site