Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorBeijing Friendship Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Nine-grid Area Division Method Assisted PVP
Procedure/SurgeryThis 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/SurgeryThis 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Nine-grid Area Division Method Assisted PVPExperimental treatment 1 intervention
Group B: Traditional PVPActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Intraoperatively2
Operative time
Total intraoperative operation time, defined as the time from surgical positioning start to complete incision suture, used to evaluate intraoperative operation efficiency.
Time frame
IntraoperativelySecondary outcomes
1
Incidence of bone cement leakage
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.
Time frame
Intraoperatively and within 24 hours after surgery2
Intraoperative fluoroscopy times and radiation dose
Record the total number of intraoperative C-arm fluoroscopy and cumulative radiation dose (mSv) to compare intraoperative radiation exposure between two groups.
Time frame
Intraoperatively3
VAS
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.
Time frame
Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery4
ODI
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.
Time frame
Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov