Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
28. července 2026 aktualizováno: Beijing Jishuitan Hospital
Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)
This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures.
Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure.
This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method.
The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
Přehled studie
Postavení
Nábor
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Chunpeng Zhao, MD / Chief Physician
- Telefonní číslo: +86 18610012704
- E-mail: zcpllza2008@163.com
Studijní místa
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100035
- Nábor
- Beijing Jishuitan Hospital
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Kontakt:
- Chunpeng Zhao, MD / Chief Physician
- Telefonní číslo: +86 18610012704
- E-mail: zcpllza2008@163.com
-
Beijing, Beijing Municipality, Čína, 100035
- Nábor
- Aerospace Center Hospital
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Kontakt:
- Yonghui Liang, MD / Chief Physician
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-A)
- Time from injury to surgery < 21 days
- Able to walk independently before injury (assistive devices allowed)
Exclusion Criteria:
- Open fractures or multiple severe traumas requiring priority treatment
- Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation/length evaluation
- Ipsilateral fractures combined with other sites
- Pathological fractures (tumor/metabolic)
- Prior complex implants in place or previous surgeries significantly affecting evaluation
- Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery)
- Cognitive impairment, poor compliance, pregnancy, or lactation
- Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury)
- Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/enrollment
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Robot-Assisted Group
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The patient undergoes automated or human-robot collaborative closed fracture reduction powered by an intelligent robotic system.
The system integrates deep-learning-based bone segmentation, automatic reduction planning, and a self-adaptive 2D-3D image registration framework to achieve sub-millimeter positioning feedback and force-position collaborative security gates.
Following successful reduction, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
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Aktivní komparátor: Traditional Group
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The patient undergoes conventional closed or open fracture reduction performed entirely by the surgical team based on traditional clinical experience under ordinary C-arm fluoroscopic guidance.
Internal fixation is achieved using standard distal tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Časové okno: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
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The percentage of patients achieving "Excellent" or "Good" anatomical closed reduction. Reduction quality is measured on post-op CT via RadiAnt DICOM Viewer and 3D Slicer based on the worst-performing of 3 dimensions:
The final reduction grade is determined by the lowest category among these parameters, and the primary outcome represents the proportion of patients graded as Excellent or Good. |
From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Operation Time Measured in Minutes
Časové okno: From initial skin incision to completion of skin closure, assessed up to 8 hours
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Total operation time will be measured in minutes and defined as the duration from initial skin incision to completion of skin closure.
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From initial skin incision to completion of skin closure, assessed up to 8 hours
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Number of Intraoperative C-Arm Fluoroscopy Shots
Časové okno: From initial skin incision to completion of skin closure, assessed up to 8 hours
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The number of intraoperative fluoroscopy shots taken using the C-arm during the surgical procedure will be recorded.
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From initial skin incision to completion of skin closure, assessed up to 8 hours
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Intraoperative Blood Loss Measured in Milliliters
Časové okno: From initial skin incision to completion of skin closure, assessed up to 8 hours
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The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters.
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From initial skin incision to completion of skin closure, assessed up to 8 hours
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Length of Hospital Stay Measured in Days
Časové okno: From hospital admission to hospital discharge, assessed up to 30 days
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The length of hospital stay will be recorded in days from admission to hospital discharge.
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From hospital admission to hospital discharge, assessed up to 30 days
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Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group
Časové okno: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
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For participants assigned to the experimental group, the robot-assisted reduction planning and execution time will be recorded in minutes.
This time is defined as the duration from completion of robotic arm setup to completion of the reduction maneuver.
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From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
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Time to Radiographic Fracture Union Assessed by Standard X-Ray
Časové okno: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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Time to radiographic fracture union will be measured in weeks using standard anteroposterior and lateral X-rays.
Fracture union is defined as cortical bridging in at least 3 of 4 cortices with no significant pain during weight-bearing.
Low-dose CT may be used to confirm fracture union in uncertain cases.
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From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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Radiographic Fracture Union Rate Assessed by Standard X-Ray
Časové okno: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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The percentage of participants achieving radiographic fracture union will be assessed using standard anteroposterior and lateral X-rays.
Low-dose CT may be used to confirm fracture union in uncertain cases.
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From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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Foot and Ankle Ability Measure-Activities of Daily Living Score
Časové okno: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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The Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) score is used to assess the functional status of patients with foot and ankle disorders.
The subscale consists of 21 items, with a maximum total raw score of 84.
The scores are converted into a percentage score ranging from 0% to 100%, where a higher score indicates a higher level of functional ability.
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From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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Lower Extremity Functional Scale Score
Časové okno: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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The Lower Extremity Functional Scale (LEFS) is used to evaluate the patient's lower extremity function and ability to perform everyday tasks.
The scale contains 20 items with a total raw score ranging from 0 to 80, where a higher score represents better functional status.
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From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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EuroQol 5-Dimension 5-Level Health Index
Časové okno: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire evaluates health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The raw response is converted into a health state index score typically ranging from 0 (representing death) to 1 (representing perfect health), with higher scores reflecting better overall quality of life.
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From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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EuroQol Visual Analogue Scale Score
Časové okno: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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The EuroQol Visual Analogue Scale (EQ VAS) provides a quantitative measure of the patient's self-rated overall health status.
The score is recorded on a visual scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
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From baseline to 1 month, 3 months, 6 months and 12 months after surgery
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Incidence of Intraoperative Complications
Časové okno: From initial skin incision to completion of skin closure, assessed up to 8 hours
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The percentage of participants experiencing intraoperative complications, including neurovascular injury, cortical perforation, abnormal bleeding, device failure, registration failure requiring manual takeover or change of reduction strategy, will be recorded.
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From initial skin incision to completion of skin closure, assessed up to 8 hours
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Incidence of Postoperative Complications
Časové okno: From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery
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The percentage of participants experiencing postoperative complications, including wound problems or infection, thrombotic events, internal fixation failure, or loss of reduction, will be recorded.
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From completion of surgery to postoperative complication assessment, assessed up to 12 months after surgery
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Incidence of Reoperation
Časové okno: From completion of surgery to reoperation assessment, assessed up to 12 months after surgery
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The percentage of participants requiring reoperation after the index surgery will be recorded.
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From completion of surgery to reoperation assessment, assessed up to 12 months after surgery
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. července 2026
Primární dokončení (Odhadovaný)
31. prosince 2027
Dokončení studie (Odhadovaný)
31. prosince 2028
Termíny zápisu do studia
První předloženo
29. června 2026
První předloženo, které splnilo kritéria kontroly kvality
28. července 2026
První zveřejněno (Aktuální)
29. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ji-Lun [K2026] No. [190]-00
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