A Multicenter Study to Evaluate the Safety and Effectiveness of SJ-11001-A and SJ-11001-B against Acute Spinal Compression Fracture Due to Primary Osteoporosis
- Conditions
- Patients with acute spinal compression fracture due to primary osteoporosis
- Registration Number
- JPRN-UMIN000048506
- Lead Sponsor
- Johnson and Johnson K.K. Medical Company
- Brief Summary
The restoration rates of vertebral height at 1 month after procedure (anterior and central part) were 31.671 +/- 26.462% and 31.835 +/- 24.622%, indicating the clinically significant restoration rate. The change in NRS pain score was - 4.5 +/- 2.4 at 7 days after operation showing a significant change from screening, indicating the clinically significant decrease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 89
Not provided
(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 (10) Patients in whom anticoagulant therapy cannot be withdrawn.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method