Patients with acute spinal compression fracture due to primary osteoporosis
Conditions
Interventions
Balloon-expanding stent for vertebral body and bone cement
Sponsors
Johnson and Johnson K.K. Medical Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients in whom bone density of the lumbar spine (L2-L4) measured by DEXA is less than 80% of YAM or bone atrophy is assessed as Grade 1 or higher by lateral X-ray views and who have painful acute spinal compression fracture in one thoracic or lumbar vertebra: the fifth thoracic vertebra to the fifth lumbar vertebra (T5-L5). As a condition of acute fracture, it has to be confirmed to be fresh fracture by MRI prior to enrollment. (2) The vertebral height measured at the anterior border part or the central part of the indicated vertebral body has to be decreased to 80% or lower of the mean of the most proximal normal (unfractured) vertebral bodies above and below the indicated vertebra body. (3) Patients with the number of fractured vertebral body other than the indicated vertebral body is not more than two. (4) Patients in whom low back pain has not been relieved despite 3 months (12 weeks) of conservative therapy after the onset [including patients in whom low back pain has continued for at least 3 months (12 weeks) with or without treatment]. The following patients who do not respond to conservative therapy are considered eligible even if the onset was within 3 months (12 weeks). (5) Patients in whom the NRS pain score is 4 or higher for low back pain at screening. (6) Patients aged 40 years or older from whom written consent can be obtained.
Exclusion criteria
Exclusion criteria: (1) Patients with any previous spinal surgery. (2) Patients with spinal fracture that prevents use of the study device. (3) Patients with pedicle fracture of the indicated vertebral body. (4) Patients with fracture of the posterior wall of the indicated vertebral body, which has been confirmed by X-ray, CT or MRI. (5) Patients with pre-existing neurological abnormal findings. (6) Patients with neurologic symptoms due to spinal cord compression or spinal canal stenosis requiring decompression. (7) Patients with low back pain that is difficult to resolve due to causes other than the target disease. (8) Patients with spinal fracture due to vertebral or spinal neoplastic disease or multiple myeloma. (9) Patients with spinal fracture due to secondary osteoporosis. (10) Patients in whom anticoagulant therapy cannot be withdrawn. (11) Patients with systemic infection, local infection of fractured vertebral body, hemorrhagic diathesis. (12) Patients to whom general anesthesia is inappropriate. (13) Patients with a previous history of hypersensitivity to bone cement (PMMA) or contrast agents. (14) Patients in whom a QOL survey is difficult due to dementia or other disorders. (15) Patients incapable of walking or standing before injury. (16) Patients in whom MRI is contraindicated. (17) Patients who are pregnant or plan to become pregnant during the study period. (18) Patients in whom spinal reconstruction with internal fixation cannot be indicated. (19) Patients with known hypersensitivity to cobalt-chromium alloy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Restoration rate of vertebral height measured using standing or sitting X-ray images from immediately before to 1 month after procedure 2) Changes in the degree of low back pain based on the NRS pain scores at screening and 7 days after procedure | — |
Countries
Japan
Contacts
Public ContactKumiko Yagi
Johnson and Johnson K.K. Medical Company Clinical Research
Outcome results
None listed