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Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method

RecruitingNAAges 50 Years - 80 YearsAllBeijing Friendship Hospital
NCT07616583 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to verify the safety and efficacy of the pedicle "Nine-grid Zoning Method" in assisting percutaneous vertebroplasty (PVP) for the treatment of lumbar osteoporotic vertebral compression fractures (OVCF) in adults. It also aims to standardize the puncture path of PVP and optimize the intraoperative operation process. The main questions it aims to answer are: * Does the "Nine-grid Zoning Method" significantly increase the rate of achieving ideal intraoperative puncture endpoints and reduce operative time compared with the traditional pedicle puncture method? * Does the novel puncture method reduce intraoperative fluoroscopy times, radiation exposure, and the incidence of postoperative bone cement leakage without increasing surgical risks? Researchers will compare the modified PVP assisted by the "Nine-grid Zoning Method" (experimental group) with conventi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with single-segment acute osteoporotic lumbar vertebral compression fracture (L1-L5), confirmed by typical MRI manifestations: low signal on T1-weighted imaging and high signal on T2-weighted and STIR sequences. * First-time reception of percutaneous vertebroplasty (PVP) surgery. * Complete preoperative imaging data including X-ray, CT, and MRI/bone scan. * Aged patients who voluntarily participate in the study and sign written informed consent. Exclusion Criteria: * Patients with old vertebral compression fractures or congenital pedicle dysplasia and lesions. * With a history of bone tumors or other systematic bone metabolic diseases. * CT examination shows incomplete or ruptured posterior wall of the fractured vertebral body. * Failure to obtain signed informed consent.
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What it tests

  • Nine-grid Area Division Method Assisted PVP
  • Traditional Standard Percutaneous Vertebroplasty (PVP)
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Where

1 site
Beijing Friendship hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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