JPRN-UMIN000048506已完成未知
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 - SJ-11001
Johnson and Johnson K.K. Medical Company0 个研究点目标入组 89 人开始时间: 2022年8月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 89
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(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 (10) Patients in whom anticoagulant therapy cannot be withdrawn.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.
研究者
相似试验
已完成
不适用
ViBone in Cervical and Lumbar Spine FusionSpondylosisHerniated Nucleus PulposusDegenerative Disc DiseaseSpondylolisthesisCervical SpondylosisNCT03425682Elutia Inc.118
终止
不适用
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek ImplantVertebral Compression FracturesOsteoporotic Vertebral Compression FracturesNCT05337696Icahn School of Medicine at Mount Sinai23
已完成
不适用
Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck FractureFemoral Neck FracturesNCT02803983The Fuzhou No 2 Hospital30
已完成
不适用
Evaluation of Post-Operative Recovery in ATTUNE® Total Knee ArthroplastyNon-inflammatory Degenerative Joint DiseaseNCT02339610DePuy Orthopaedics200
终止
不适用
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic CancerMetastatic CancersVertebral FractureMultiple MyelomaNCT02376933University of Arizona11