Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures

Official title

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)

Overview

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.

Interventions

• Device Robot-assisted closed reduction
  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
• Procedure Traditional surgeon-led reduction
  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.

Primary outcome measures

• Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria [Time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery]

Secondary outcome measures (12)

• Total Operation Time Measured in Minutes [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Number of Intraoperative C-Arm Fluoroscopy Shots [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Intraoperative Blood Loss Measured in Milliliters [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]
• Length of Hospital Stay Measured in Days [Time frame: From hospital admission to hospital discharge, assessed up to 30 days]
• Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group [Time frame: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours]
• Time to Radiographic Fracture Union Assessed by Standard X-Ray [Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery]
• Radiographic Fracture Union Rate Assessed by Standard X-Ray [Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery]
• Foot and Ankle Ability Measure-Activities of Daily Living Score [Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• Lower Extremity Functional Scale Score [Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• EuroQol 5-Dimension 5-Level Health Index [Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• EuroQol Visual Analogue Scale Score [Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery]
• Incidence of Intraoperative Complications [Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Aerospace Center Hospital — Beijing
• Beijing Jishuitan Hospital — Beijing

Identifiers

NCT: NCT07733271 · Ji-Lun [K2026] No. [190]-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗