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

27 mai 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

68

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100050
        • Recrutement
        • Beijing Friendship hospital, Capital Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Nine-grid Area Division Method Assisted PVP
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.
Comparateur actif: 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.
Procédure: Traditional Standard Percutaneous Vertebroplasty (PVP)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of cases reaching ideal intraoperative puncture endpoint
Délai: 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.
Intraoperatively
Operative time
Délai: Intraoperatively
Total intraoperative operation time, defined as the time from surgical positioning start to complete incision suture, used to evaluate intraoperative operation efficiency.
Intraoperatively

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of bone cement leakage
Délai: 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.
Intraoperatively and within 24 hours after surgery
Intraoperative fluoroscopy times and radiation dose
Délai: Intraoperatively
Record the total number of intraoperative C-arm fluoroscopy and cumulative radiation dose (mSv) to compare intraoperative radiation exposure between two groups.
Intraoperatively
VAS
Délai: 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.
Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
ODI
Délai: 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.
Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
SF-36 scores
Délai: 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.
Postoperative day 1, discharge, 3 months, 6 months, and 1 year after surgery
Incidence of postoperative vertebral re-fracture
Délai: 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.
Up to 1 year after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing Friendship Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2024

Achèvement primaire (Estimé)

31 octobre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2024-P2-145

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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