Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures
30 de maio de 2026 atualizado por: Junbo Liang
Comparing the Efficacy and Safety of Robot Assisted Treatment Versus Conventional Surgery in Patients With Tile B and C Pelvic Fractures
This prospective randomized controlled trial aims to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
Eligible patients will be stratified according to Tile fracture classification and randomly assigned in a 1:1 ratio to receive either robot assisted minimally invasive fixation or conventional surgical treatment.
Primary and secondary outcomes include pain relief, early mobilization, functional recovery, imaging outcomes, perioperative complications, venous thromboembolism events, laboratory parameters, opioid consumption, and healthcare resource utilization.
The study aims to provide evidence for optimizing surgical treatment strategies for unstable pelvic fractures.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted treatment versus conventional surgery in patients with Tile B and C pelvic fractures.
A total of 88 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted treatment group or the conventional surgery group. Randomization will be stratified according to Tile fracture classification (Tile B or Tile C) using a computer generated randomization sequence.
Eligible participants include adult patients diagnosed with Tile B or Tile C pelvic fractures within 3 weeks after injury. The primary objective is to compare perioperative outcomes, pain control, early mobilization, functional recovery, imaging outcomes, complications, opioid consumption, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement. Patients in the conventional surgery group will undergo standard open surgical fixation according to fracture characteristics and surgeon judgment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture healing, laboratory parameters, venous thromboembolism events, opioid consumption, perioperative indicators, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal surgical treatment strategy for Tile B and C pelvic fractures.
Tipo de estudo
Intervencional
Inscrição (Estimado)
88
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: Junbo Liang, Dr.
- Número de telefone: 0576-85190463
- E-mail: liangjb@enzemed.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:
- Age ≥ 18 years
- Diagnosis of Tile B or Tile C pelvic fracture
- Injury duration less than 3 weeks
- Ability to provide written informed consent
Exclusion Criteria:
- Severe open injury or skin infection at the surgical site
- Hemodynamic instability preventing anesthesia or surgery
- Severe psychiatric disorders or dementia
- Severe obesity affecting imaging quality
- Severe systemic diseases preventing surgery
- Pathological fracture
- Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
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: Robot Assisted Treatment Group
Participants undergo robot assisted minimally invasive fixation using robotic navigation assisted percutaneous screw placement for Tile B and C pelvic fractures.
|
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
|
|
Comparador Ativo: Conventional Surgery Group
Participants undergo conventional open surgical fixation for Tile B and C pelvic fractures.
|
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
Prazo: At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Visual Analog Scale (VAS) for pain.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain severity.
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At 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Majeed Pelvic Function Score
Prazo: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
The Majeed Pelvic Function Score is used to evaluate functional recovery after pelvic fracture treatment.
Scores range from 0 to 100, with higher scores indicating better functional outcomes and quality of life.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
EuroQol 5-Dimension 3-Level Questionnaire
Prazo: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Health related quality of life assessed using the EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L).
The EQ-5D index score ranges from values below 0 (health states considered worse than death) to 1.0 (full health).
Higher scores indicate better health related quality of life.
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Short Musculoskeletal Function Assessment (SMFA)
Prazo: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Musculoskeletal function assessed using the 46-item Short Musculoskeletal Function Assessment (SMFA).
Raw questionnaire scores are transformed to a standardized score ranging from 0 to 100.
Higher scores indicate worse musculoskeletal function and greater disability.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Imaging Outcomes and Fracture Healing
Prazo: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Assessment of fracture healing, secondary displacement, bone mineral density changes, and muscle mass changes using pelvic CT and imaging examinations.
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At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Complication
Prazo: From treatment initiation to 1 year follow up
|
From treatment initiation to 1 year follow up
|
|
|
Opioid Consumption
Prazo: Postoperative Days 0-3
|
Assessment of cumulative opioid consumption during hospitalization
|
Postoperative Days 0-3
|
|
Serum C-Reactive Protein Level
Prazo: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
|
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D-Dimer Level
Prazo: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
|
|
Hemoglobin Level
Prazo: Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
Preoperative, Day 1, Day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment.
|
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Operative Time
Prazo: Perioperative
|
Duration of surgery measured in minutes.
|
Perioperative
|
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Intraoperative Blood Loss
Prazo: Perioperative
|
Estimated intraoperative blood loss measured in milliliters.
|
Perioperative
|
|
Length of Surgical Incision
Prazo: Perioperative
|
Length of skin incision measured in centimeters.
|
Perioperative
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Lu Z, Xiuxiu H, Xing B. Retrospective analysis of the use of orthopedic reduction robots in treating low-energy osteoporotic unstable pelvic fractures in the elderly. J Orthop Surg Res. 2025 Sep 26;20(1):844. doi: 10.1186/s13018-025-06258-1.
- Zwingmann J, Konrad G, Kotter E, Sudkamp NP, Oberst M. Computer-navigated iliosacral screw insertion reduces malposition rate and radiation exposure. Clin Orthop Relat Res. 2009 Jul;467(7):1833-8. doi: 10.1007/s11999-008-0632-6. Epub 2008 Nov 26.
- Hoffmann MF, Yilmaz E, Norvel DC, Schildhauer TA. Navigated iliac screw placement may reduce radiation and OR time in lumbopelvic fixation of unstable complex sacral fractures. Eur J Orthop Surg Traumatol. 2021 Oct;31(7):1427-1433. doi: 10.1007/s00590-021-02892-7. Epub 2021 Feb 16.
- Gericke L, Fritz A, Osterhoff G, Josten C, Pieroh P, Hoch A. Percutaneous operative treatment of fragility fractures of the pelvis may not increase the general rate of complications compared to non-operative treatment. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3729-3735. doi: 10.1007/s00068-021-01660-w. Epub 2021 Apr 3.
- Ran D, Wang C. Efficacy and safety of different fixation methods for unstable anterior pelvic ring fractures: a Bayesian network meta-analysis. Ann Med. 2025 Dec;57(1):2563000. doi: 10.1080/07853890.2025.2563000. Epub 2025 Oct 6.
- Lu S, Liu F, Xu W, Zhou X, Li L, Zhou D, Li Q, Dong J. Management of Open Tile C Pelvic Fractures and Their Outcomes: A Retrospective Study of 30 Cases. Ther Clin Risk Manag. 2022 Sep 10;18:929-937. doi: 10.2147/TCRM.S378740. eCollection 2022.
- de Ridder VA, Whiting PS, Balogh ZJ, Mir HR, Schultz BJ, Routt MC. Pelvic ring injuries: recent advances in diagnosis and treatment. OTA Int. 2023 Jun 16;6(3 Suppl):e261. doi: 10.1097/OI9.0000000000000261. eCollection 2023 Jun.
- Tienpratarn W, Nakpipat N, Yuksen C, Wongwaisayawan S, Phootothum Y, Jaiboon S. Clinical Associated Factors of Tile B/C Type of Pelvic Ring Fractures; a Retrospective Cross-sectional study. Arch Acad Emerg Med. 2024 May 12;12(1):e49. doi: 10.22037/aaem.v12i1.2243. eCollection 2024.
- Ding H, Wang W, Sun W, Liu L, Huang M, Han D, Lu Y, Zhou J, Pan J. Clinical characteristics and mortality risk factors in polytrauma patients with pelvic fractures: a retrospective study based on an integrated multidisciplinary treatment approach. Int J Emerg Med. 2025 Oct 6;18(1):192. doi: 10.1186/s12245-025-00990-5.
- Ohla J, Walus P, Wicinski M, Malkowski B, Turon B, Jablonski A, Gawryjolek M, Kellett K, Zabrzynski J. Pelvic Fractures in Adults and the Importance of Associated Injuries-A Current Multi-Disciplinary Approach. Clin Pract. 2025 Jul 11;15(7):130. doi: 10.3390/clinpract15070130.
- Hermans E, Biert J, Edwards MJR. Epidemiology of Pelvic Ring Fractures in a Level 1 Trauma Center in the Netherlands. Hip Pelvis. 2017 Dec;29(4):253-261. doi: 10.5371/hp.2017.29.4.253. Epub 2017 Dec 1.
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 (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de junho de 2027
Conclusão do estudo (Estimado)
30 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
24 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de maio de 2026
Primeira postagem (Real)
3 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- K20260304
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