Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures

NCT07738380 | Recruiting

• 1 other identifier: Ji-Lun [K2026] No. 188-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are: Does robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma. Participants will: Undergo standardized screening to ensure they meet the inclusion criteria for acute, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 32). Be randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation. Complete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.

Conditions

Femoral Shaft Fractures; Femur Fractures; Femur Fracture

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

  Closed fracture reduction will be assessed on postoperative CT using a 3D quantitative grading system. Three dimensions will be graded as Excellent, Good, Fair, or Poor: displacement, angular deformity, and rotational deformity. The thresholds are \<=3 mm/degree for Excellent, \>3-5 mm/degree for Good, \>5-10 mm/degree for Fair, and \>10 mm/degree for Poor. The final grade will be the lowest grade across the three dimensions, and the excellent/good rate is the percentage of participants with a final grade of Excellent or Good.

  From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery

Secondary Outcomes (12)

• Total Operation Time Measured in Minutes

  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

• Change from Baseline in Lower Extremity Functional Scale Score (LEFS)

  From baseline to 1 month, 3 months, 6 months, and 12 months after surgery

• Change from Baseline in EuroQol 5-Dimension 5-Level Score( EQ-5D-5L)

  From baseline to 1 month, 3 months, 6 months, and 12 months after surgery

• Number of Intraoperative C-Arm Fluoroscopy Shots

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

Study Arms (2)

Robot-Assisted Close Reduction

EXPERIMENTAL

Patients in this arm will undergo autonomous closed reduction of the fracture assisted by a robotic system, followed by internal fixation performed by the surgeon.

Procedure: Robot-Assisted Closed Reduction

Traditional Close Reduction

ACTIVE COMPARATOR

Patients in this arm will undergo traditional closed reduction (or open reduction if necessary) performed manually by the surgeon, followed by conventional internal fixation.

Procedure: Conventional Closed Reduction

Interventions

Robot-Assisted Closed Reduction PROCEDURE

Patients in this group will undergo robotic-assisted closed reduction of the femoral shaft fracture. The procedure utilizes a robotic system for intraoperative navigation and automated reduction planning based on preoperative computed tomography (CT) imaging. The robotic system assists the surgeon in achieving precise fracture alignment. Following successful reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.

Robot-Assisted Close Reduction

Conventional Closed Reduction PROCEDURE

Patients in this group will undergo traditional manual closed reduction of the femoral shaft fracture. The reduction will be performed by the surgeon using standardized traction and manipulation techniques under real-time fluoroscopic guidance. Following manual reduction, routine internal fixation (intramedullary nailing) will be performed by the surgeon.

Traditional Close Reduction

Eligibility Criteria

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

You may qualify if:

• Age 18 to 80 years, inclusive.
• Unilateral, acute, closed femoral shaft fracture.
• AO/OTA classification 32-A, 32-B, or 32-C femoral shaft fracture.
• Time from injury to surgery no more than 21 days.
• Ability to walk independently before injury, with or without assistive devices.
• Ability to provide written informed consent.

You may not qualify if:

• Open fracture.
• Multiple severe trauma requiring immediate priority management.
• Asymmetry of the lower limbs.
• History of ipsilateral femoral shaft malunion.
• History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length.
• Ipsilateral fracture at another site.
• Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology.
• Complex hardware from previous ipsilateral surgery.
• History of ipsilateral surgery that significantly affects clinical or radiographic evaluation.
• Active infection.
• Severe underlying medical condition that makes the patient unable to tolerate surgery.
• Cognitive impairment that prevents study participation or follow-up.
• Poor compliance with study procedures or follow-up.
• Pregnancy or lactation.
• Judged by the investigators to be unsuitable for enrollment.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Chunpeng Zhao

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: July 8, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)