PROTECT - Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Improvement of sagittal balance
研究概览
简要总结
The purpose of this study is to collect clinical and radiographic outcomes in patients undergoing vertebroplasty procedures for the treatment of osteoporotic or pathological fractures of the vertebral body to understand the role of sagittal balance in patient outcomes. To support this objective, the sagittal balance measurement of sagittal vertical axis (SVA), NRS back pain, Quebec Back Pain Disability Scale (Quebec) score, and complications will be collected. The secondary purpose of the study is to review the role of sagittal balance and adjacent facet joint arthropathy treatment in patients with vertebral body fractures due to osteoporosis or tumor.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years.
- •Patients requiring vertebroplasty for the fixation of symptomatic pathological fractures of the thoracic or lumbar vertebral body resulting from osteoporosis or tumor.
- •Symptomatic vertebral compression fracture(s) confirmed by MRI with bone marrow oedema on T2/STIR sequences.
- •Diagnosis of osteoporosis (clinically and confirmed on DXA with quantifiable BMD) or pathological fracture due to tumor
- •Patients with 1 or more vertebral compression fractures of the thoracic or lumbar spine Note: Patients with a current vertebral compression fracture who also have a previous history of vertebral compression fractures of the thoracic or lumbar spine may be included.
- •Study Specific Inclusion Criterion • Signed informed consent
排除标准
- •Infection
- •Vertebral body collapse to less than 1/3 (33%) of original height
- •Vertebral plana (>90% vertebral body collapse)
- •Spinal stenosis (retro pulsed fragments).
- •Unstable spine warranting surgical stabilization
- •Prophylactic treatment of any vertebrae with vertebroplasty
- •Irreversible life threating bleeding disorders
- •End stage kidney disease
- •Drug dependence (IVDU)
- •Pregnancy
- •Study Specific Exclusion Criterion:
- •Unable or unwilling to follow the standard of care prescribed follow-up visits
结局指标
主要结局
Improvement of sagittal balance
时间窗: Up to 12 months post index surgery
measurement of sagittal vertical axis (SVA)
次要结局
- Quebec Score(6-12 months post index surgery)
- Improvement in Back Pain(Up to 12 months post index surgery)
- Complications(Up to 12 months post-index surgery)
研究者
Prof Nicolas Theumann
Professor
Hirslanden Clinique Bois-Cerf Lausanne