Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method
27 maggio 2026 aggiornato da: Qi Fei, Beijing Friendship Hospital
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
Panoramica dello studio
Stato
Reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
68
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Qi Fei
- Numero di telefono: +86 13641225060
- Email: spinefei@126.com
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100050
- Reclutamento
- Beijing Friendship Hospital, Capital Medical University
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Contatto:
- Qi Fei
- Numero di telefono: 13641225060
- Email: spinefei@126.com
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Nine-grid Area Division Method Assisted PVP
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.
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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.
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Comparatore attivo: Traditional PVP
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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of cases reaching ideal intraoperative puncture endpoint
Lasso di tempo: Intraoperatively
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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.
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Intraoperatively
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Operative time
Lasso di tempo: Intraoperatively
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Total intraoperative operation time, defined as the time from surgical positioning start to complete incision suture, used to evaluate intraoperative operation efficiency.
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Intraoperatively
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of bone cement leakage
Lasso di tempo: Intraoperatively and within 24 hours after surgery
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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.
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Intraoperatively and within 24 hours after surgery
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Intraoperative fluoroscopy times and radiation dose
Lasso di tempo: Intraoperatively
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Record the total number of intraoperative C-arm fluoroscopy and cumulative radiation dose (mSv) to compare intraoperative radiation exposure between two groups.
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Intraoperatively
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VAS
Lasso di tempo: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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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.
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Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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ODI
Lasso di tempo: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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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.
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Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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SF-36 scores
Lasso di tempo: Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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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.
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Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
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Incidence of postoperative vertebral re-fracture
Lasso di tempo: Up to 1 year after surgery
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Record the number of patients with adjacent or injured vertebral re-fracture during follow-up to evaluate long-term surgical prognosis.
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Up to 1 year after surgery
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2024
Completamento primario (Stimato)
31 ottobre 2026
Completamento dello studio (Stimato)
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
21 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 maggio 2026
Primo Inserito (Effettivo)
1 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2024-P2-145
Piano per i dati dei singoli partecipanti (IPD)
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INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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