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

NCT07733271 | Recruiting DMC

• 1 other identifier: Ji-Lun [K2026] No. [190]-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Distal Tibial Fracture; Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria

  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: 1. Separation/shortening displacement: Excellent (≤3mm), Good (\>3-5mm), Fair (\>5-10mm), Poor (\>10mm). 2. Angulation deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). 3. Rotational deformity: Excellent (≤3°), Good (\>3-5°), Fair (\>5-10°), Poor (\>10°). 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

Secondary Outcomes (14)

• Total Operation Time Measured in Minutes

  From initial skin incision to completion of skin closure, assessed up to 8 hours

• Number of Intraoperative C-Arm Fluoroscopy Shots

  From initial skin incision to completion of skin closure, assessed up to 8 hours

• Intraoperative Blood Loss Measured in Milliliters

  From initial skin incision to completion of skin closure, assessed up to 8 hours

• Length of Hospital Stay Measured in Days

  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

  From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours

Study Arms (2)

Robot-Assisted Group

EXPERIMENTAL

Device: Robot-assisted closed reduction

Traditional Group

ACTIVE COMPARATOR

Procedure: Traditional surgeon-led reduction

Interventions

Robot-assisted closed reduction DEVICE

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.

Robot-Assisted Group

Traditional surgeon-led reduction PROCEDURE

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.

Traditional Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead
• Aerospace Center Hospital: collaborator

Study Sites (2)

Aerospace Center Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Chunpeng Zhao, MD / Chief Physician

CONTACT

+86 18610012704; zcpllza2008@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)