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

NCT07616583 | Recruiting

• 1 other identifier: 2024-P2-145
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoporotic Vertebral Compression Fractures; Vertebroplasty

Keywords

Nine-grid Area Division Method; PVP; OVCF; Vertebral pedicle puncture

Outcome Measures

Primary Outcomes (2)

• Proportion of cases reaching ideal intraoperative puncture endpoint

  The number and proportion of patients who achieve the standardized ideal puncture endpoint during operation. Ideal endpoint is defined as the puncture needle reaches the anterior 1/3 of the vertebral body on lateral fluoroscopy and locates at the vertebral midline on anteroposterior fluoroscopy, with qualified pedicle channel positioning.

  Intraoperatively

• Operative time

  Total intraoperative operation time, defined as the time from surgical positioning start to complete incision suture, used to evaluate intraoperative operation efficiency.

  Intraoperatively

Secondary Outcomes (6)

• Incidence of bone cement leakage

  Intraoperatively and within 24 hours after surgery

• Intraoperative fluoroscopy times and radiation dose

  Intraoperatively

• VAS

  Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery

• ODI

  Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery

• SF-36 scores

  Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery

Study Arms (2)

Nine-grid Area Division Method Assisted PVP

EXPERIMENTAL

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.

Procedure: Nine-grid Area Division Method Assisted PVP

Traditional PVP

ACTIVE COMPARATOR

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.

Procedure: Traditional Standard Percutaneous Vertebroplasty (PVP)

Interventions

Nine-grid Area Division Method Assisted PVP PROCEDURE

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, anesthesia, needle insertion depth adjustment, bone cement mixing and injection, and incision suture follow standard PVP protocols. Perioperative management and 1-year systematic postoperative follow-up are performed uniformly.

Nine-grid Area Division Method Assisted PVP

Traditional Standard Percutaneous Vertebroplasty (PVP) PROCEDURE

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 to the experimental group, ensuring consistent intervention conditions except for the puncture positioning method.

Traditional PVP

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Central Study Contacts

Qi Fei

CONTACT

+86 13641225060; spinefei@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 1, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)