Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
28 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
60
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Chunpeng Zhao, MD / Chief Physician
- Telefoonnummer: +86 18610012704
- E-mail: zcpllza2008@163.com
Studie Locaties
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100035
- Werving
- Beijing Jishuitan Hospital
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Contact:
- Chunpeng Zhao, MD / Chief Physician
- Telefoonnummer: +86 18610012704
- E-mail: zcpllza2008@163.com
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Beijing, Beijing Municipality, China, 100035
- Werving
- Aerospace Center Hospital
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Contact:
- Yonghui Liang, MD / Chief Physician
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total Operation Time Measured in Minutes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2026
Primaire voltooiing (Geschat)
31 december 2027
Studie voltooiing (Geschat)
31 december 2028
Studieregistratiedata
Eerst ingediend
29 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 juli 2026
Eerst geplaatst (Werkelijk)
29 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
28 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Ji-Lun [K2026] No. [190]-00
Plan Individuele Deelnemersgegevens (IPD)
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Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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