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

Capital Medical University

Status: Enrolling

Conditions: Vertebroplasty; Osteoporotic Vertebral Compression Fractures

Treatments: Procedure: Traditional Standard Percutaneous Vertebroplasty (PVP); Procedure: Nine-grid Area Division Method Assisted PVP

Study type: Interventional

Funder types: Other

Identifiers

NCT07616583

2024-P2-145

Details and patient eligibility

About

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

Enrollment: 68 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Nine-grid Area Division Method Assisted PVP

Experimental group

Description:

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.

Treatment:

Procedure: Nine-grid Area Division Method Assisted PVP

Traditional PVP

Active Comparator group

Description:

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.

Treatment:

Procedure: Traditional Standard Percutaneous Vertebroplasty (PVP)