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

Обзор

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 conventional PVP adopting the traditional "10 o'clock/2 o'clock" pedicle puncture point (control group) to confirm the clinical superiority and safety of the new standardized puncture path. Participants will: * Receive unilateral transpedicular PVP surgery via either the nine-grid zoning puncture path or the traditional puncture path for single-segment acute lumbar OVCF * Complete preoperative baseline examinations including bone density detection, VAS pain score, ODI functional score and SF-36 quality of life score assessment * Receive standardized intraoperative data recording covering operative time, fluoroscopy frequency, radiation dose, bone cement filling and leakage conditions * Undergo postoperative follow-up at 1 day after surgery, discharge, 3 months, 6 months and 1 year after operation, with regular imaging re-examination and scale evaluation to monitor fracture recovery and postoperative complications

Вмешательства

• Процедура Nine-grid Area Division Method Assisted PVP
  This intervention applies a novel pedicle nine-grid zoning technique for puncture positioning during unilateral transpedicular PVP. Under intraoperative C-arm fluoroscopy, the vertebral pedicle projection is divided into a nine-grid area to determine the optimal bony puncture surface and accurate puncture entry point, replacing the traditional fixed puncture site. The standardized zoning positioning reduces repeated needle adjustment. All other surgical procedures including routine disinfection,
• Процедура Traditional Standard Percutaneous Vertebroplasty (PVP)
  This intervention adopts conventional unilateral transpedicular PVP with classic empirical puncture positioning. The standard puncture entry point is defined as the left 10 o'clock and right 2 o'clock position of the pedicle projection. Surgeons adjust the puncture needle repeatedly via real-time C-arm fluoroscopy to reach the ideal intraoperative puncture endpoint. All surgical procedures, perioperative care, postoperative rehabilitation guidance, and long-term follow-up regimen are identical t

Первичные конечные точки

• Proportion of cases reaching ideal intraoperative puncture endpoint [Срок оценки: Intraoperatively]
• Operative time [Срок оценки: Intraoperatively]

Вторичные конечные точки (6)

• Incidence of bone cement leakage [Срок оценки: Intraoperatively and within 24 hours after surgery]
• Intraoperative fluoroscopy times and radiation dose [Срок оценки: Intraoperatively]
• VAS [Срок оценки: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery]
• ODI [Срок оценки: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery]
• SF-36 scores [Срок оценки: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery]
• Incidence of postoperative vertebral re-fracture [Срок оценки: Up to 1 year after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Friendship hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07616583 · 2024-P2-145

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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