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

Recruiting now · Not applicable

Conditions studied: Osteoporotic Vertebral Compression Fractures, Vertebroplasty

In brief

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

Key facts

Study ID

NCT07616583

Run by

Beijing Friendship Hospital

People needed

68

Starts

2024-01-01

Expected to finish

2026-12-31

Last updated by the study team

2026-06-01

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Beijing Friendship hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.