Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
28 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
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: Chunpeng Zhao, MD / Chief Physician
- Numero di telefono: +86 18610012704
- Email: zcpllza2008@163.com
Luoghi di studio
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Beijing Municipality
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Beijing, Beijing Municipality, Cina, 100035
- Reclutamento
- Beijing Jishuitan Hospital
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Contatto:
- Chunpeng Zhao, MD / Chief Physician
- Numero di telefono: +86 18610012704
- Email: zcpllza2008@163.com
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Beijing, Beijing Municipality, Cina, 100035
- Reclutamento
- Aerospace Center Hospital
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Contatto:
- Yonghui Liang, MD / Chief Physician
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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:
- 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
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: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Operation Time Measured in Minutes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
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 (Effettivo)
1 luglio 2026
Completamento primario (Stimato)
31 dicembre 2027
Completamento dello studio (Stimato)
31 dicembre 2028
Date di iscrizione allo studio
Primo inviato
29 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
28 luglio 2026
Primo Inserito (Effettivo)
29 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Ji-Lun [K2026] No. [190]-00
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .