Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method
27 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
68
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Qi Fei
- Número de telefone: +86 13641225060
- E-mail: spinefei@126.com
Locais de estudo
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100050
- Recrutamento
- Beijing Friendship Hospital, Capital Medical University
-
Contato:
- Qi Fei
- Número de telefone: 13641225060
- E-mail: spinefei@126.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of cases reaching ideal intraoperative puncture endpoint
Prazo: 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
Prazo: Intraoperatively
|
Total intraoperative operation time, defined as the time from surgical positioning start to complete incision suture, used to evaluate intraoperative operation efficiency.
|
Intraoperatively
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of bone cement leakage
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2024
Conclusão Primária (Estimado)
31 de outubro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2024-P2-145
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .