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NCT Number: NCT07616583

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

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

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Key information

Conditions

Osteoporotic Vertebral Compression Fractures Vertebroplasty

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Qi Fei

CONTACT

[email protected]

13641225060

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of cases reaching ideal intraoperative puncture endpoint

    Time frame: Intraoperatively

    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.

  2. Operative time

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Incidence of bone cement leakage

    Time frame: Intraoperatively and within 24 hours after surgery

    The number and proportion of patients with intraoperative or immediate postoperative bone cement leakage detected by C-arm fluoroscopy, and the classification of leakage types, to evaluate surgical safety.

  2. Intraoperative fluoroscopy times and radiation dose

    Time frame: Intraoperatively

    Record the total number of intraoperative C-arm fluoroscopy and cumulative radiation dose (mSv) to compare intraoperative radiation exposure between two groups.

  3. VAS

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

    Evaluate postoperative pain degree via Visual Analogue Scale (VAS) to assess long-term clinical efficacy.The VAS is a 10-point continuous scale used to evaluate subjective pain intensity. The minimum score is 0 points, representing no pain at all. The maximum score is 10 points, representing the most severe and unbearable pain. A lower VAS score indicates milder pain and better clinical recovery, while a higher score indicates worse pain status and poorer symptomatic improvement.

  4. ODI

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

    Evaluate postoperative pain degree via lumbar function via Oswestry Disability Index (ODI) to assess long-term clinical efficacy.The ODI is a validated questionnaire for assessing lumbar spine-related functional disability. The total score ranges from 0 points to 100 points. The minimum score (0 points) means no functional disability and completely normal lumbar activity. The maximum score (100 points) means severe lumbar dysfunction and complete inability to perform daily activities. Lower ODI scores reflect better lumbar function and improved living ability, whereas higher scores represent more serious functional impairment and worse surgical efficacy.

  5. SF-36 scores

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

    Evaluate postoperative quality of life via SF-36 scale to assess long-term clinical efficacy.The SF-36 is a comprehensive scale for evaluating overall quality of life and general health status. Each dimension and the aggregated total score range from 0 points to 100 points. The minimum score (0 points) indicates the worst health status and extremely poor quality of life. The maximum score (100 points) indicates perfect physical and mental health with excellent daily living quality. Unlike VAS and ODI, a higher SF-36 score represents better health condition and superior postoperative quality of life, while a lower score indicates poorer recovery and worse health outcomes.

  6. Incidence of postoperative vertebral re-fracture

    Time frame: Up to 1 year after surgery

    Record the number of patients with adjacent or injured vertebral re-fracture during follow-up to evaluate long-term surgical prognosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Fei

CONTACT

[email protected]

+86 13641225060

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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