Vertebroplasty Clinical Trials

Clinical trials related to Vertebroplasty Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Friendship hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Qi Fei
spinefei@126.com
+86 13641225060
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 68
Treatments
Experimental: Nine-grid Area Division Method Assisted PVP
Participants in this group undergo unilateral transpedicular percutaneous vertebroplasty (PVP) for single-segment acute lumbar osteoporotic vertebral compression fractures. Based on the newly proposed pedicle nine-grid zoning theory, surgeons identify the optimal puncture surface and puncture site under C-arm fluoroscopy guidance. Except for the standardized nine-grid puncture positioning method, all other intraoperative operations, perioperative management, and postoperative treatment are completely consistent with the control group. All subjects receive unified preoperative baseline evaluation, standardized intraoperative data collection, and regular postoperative follow-up up to 1 year after surgery.
Active_comparator: Traditional PVP
Participants in this group receive conventional unilateral transpedicular PVP for single-segment acute lumbar osteoporotic vertebral compression fractures. The traditional classic puncture positioning standard is adopted, with the ideal pedicle puncture point located at the 10 o'clock (left) and 2 o'clock (right) projection position. Surgeons adjust the puncture needle position repeatedly under intraoperative C-arm fluoroscopy to reach the ideal puncture endpoint. Perioperative nursing, surgical operation specifications, postoperative rehabilitation guidance and follow-up schedule are identical to those of the experimental group to ensure consistent baseline conditions of the two groups.
Related Therapeutic Areas
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov

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