Robot Assisted Treatment Versus Conventional Surgery for Tile B and C Pelvic Fractures
30 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
88
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: Junbo Liang, Dr.
- Numero di telefono: 0576-85190463
- Email: liangjb@enzemed.com
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:
- 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
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 |
|---|---|
|
Sperimentale: 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.
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Comparatore attivo: Conventional Surgery Group
Participants undergo conventional open surgical fixation for Tile B and C pelvic fractures.
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Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of unstable pelvic fractures.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
Lasso di tempo: 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
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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
|
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Majeed Pelvic Function Score
Lasso di tempo: 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.
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
EuroQol 5-Dimension 3-Level Questionnaire
Lasso di tempo: 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)
Lasso di tempo: 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.
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Imaging Outcomes and Fracture Healing
Lasso di tempo: 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.
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Complication
Lasso di tempo: From treatment initiation to 1 year follow up
|
From treatment initiation to 1 year follow up
|
|
|
Opioid Consumption
Lasso di tempo: Postoperative Days 0-3
|
Assessment of cumulative opioid consumption during hospitalization
|
Postoperative Days 0-3
|
|
Serum C-Reactive Protein Level
Lasso di tempo: 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.
|
|
|
D-Dimer Level
Lasso di tempo: 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
Lasso di tempo: 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.
|
|
|
Operative Time
Lasso di tempo: Perioperative
|
Duration of surgery measured in minutes.
|
Perioperative
|
|
Intraoperative Blood Loss
Lasso di tempo: Perioperative
|
Estimated intraoperative blood loss measured in milliliters.
|
Perioperative
|
|
Length of Surgical Incision
Lasso di tempo: Perioperative
|
Length of skin incision measured in centimeters.
|
Perioperative
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
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 (Stimato)
1 giugno 2026
Completamento primario (Stimato)
1 giugno 2027
Completamento dello studio (Stimato)
30 dicembre 2028
Date di iscrizione allo studio
Primo inviato
24 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
30 maggio 2026
Primo Inserito (Effettivo)
3 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- K20260304
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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