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

NCT07738406 | Recruiting DMC

• 1 other identifier: Ji-Lun [K2026] No. [189]-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.

Conditions

Supracondylar Femoral Fractures; Femoral Fractures

Keywords

Fracture Fixation; Robotic Surgical Procedures; Minimally Invasive Surgical Procedures; Anatomic Reduction Standard; Artificial Intelligence

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

Automated/human-robot collaborative closed fracture reduction powered by an intelligent robotic system, followed by distal femoral locking plate fixation via MIPO technique

Device: Robot-assisted closed reduction

Traditional Group

ACTIVE COMPARATOR

Conventional closed or open fracture reduction performed entirely by the surgical team under ordinary C-arm fluoroscopy, followed by standard fixation (plates or intramedullary nails)

Device: Conventional fracture reduction and internal fixation

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, internal fixation is performed using a distal femoral locking compression plate (LCP-DF) via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.

Robot-Assisted Group

Conventional fracture reduction and internal fixation DEVICE

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 femoral locking plates or intramedullary nails (with dual-plate fixation permitted when indicated for medial bone defects or collapse) 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:

• Age between 18 and 80 years old
• Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-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 femur, or pre-existing deformities significantly affecting rotation/length evaluation
• Unilateral fractures combined with other sites
• Pathological fractures (tumor or 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
• Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace)
• Refused randomization or 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

Femoral Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

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: July 8, 2026
• First Posted: July 31, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)