The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China
Hunan provincial people's hospital
Changsha, Hunan, China
The first affiliated hospital of Suzhou university
Suzhou, Jiangsu, China
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time frame: Baseline and 6 months
The Change of Index Vertebral Body Angle From Baseline at 6 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time frame: Baseline and 6 months
The Change of NRS Score From Baseline at 1 Day and 3 Months
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time frame: Baseline, 1 day, and 3 months
The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months
ODI Questionnaire is used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time frame: Baseline, 1 day, 3 months, and 6 months
The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS/MCS is between 0 and 100, with higher scores denoting better quality of life.
Time frame: Baseline, 1 day, 3 months, and 6 months
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Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months
Vertebral Body Height in the lateral projection will be measured at each treated vertebra as well as the next adjacent vertebrae (superior and inferior) without fracture and reported in millimeters. Vertebral Body Height is the distance between comparable points on the superior and inferior endplates of the vertebral body at the posterior (Hp), midline (Hm) and anterior (Ha) locations。
Time frame: 1 day, 3 months, and 6 months
Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
Time frame: Baseline, 1 day and 3 months
Number of Participants With Adverse Events Reported Through 6 Months
Adverse events reported through 6 months, in particular, the following events will be reported: * Bone Cement Implantation Syndrome; * Bone Cement leakage; * Vertebral body compression fracture; * Adjacent vertebral body fracture;
Time frame: 6 months