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

Summary

The goal of this clinical trial is to compare the clinical effectiveness and safety of robot-assisted autonomous closed reduction versus traditional manual closed reduction in adult patients aged 18 to 80 years with acute, closed intertrochanteric femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 31-A). The main question it aims to answer is:

Whether robot-assisted autonomous closed reduction can achieve a significantly higher rate of excellent and good bone fracture reduction compared to traditional manual reduction, as rigorously evaluated by low-dose computed tomography (CT) and a three-dimensional (3D) quantitative standard.

Researchers will compare the robot-assisted autonomous closed reduction group (intervention group) to the traditional manual closed reduction group (control group) to see if the robotic system significantly improves 3D anatomical reduction precision, reduces intraoperative fluoroscopy times and radiation doses, shortens operation times, and ultimately enhances long-term clinical hip functions and health-related quality of life.

Participants will be asked to do the following tasks:

Complete baseline medical screening, standard hip X-rays, and bilateral full-length thin-layer CT scans before the surgery.

Undergo a 1:1 randomized allocation after anesthesia to receive either robot-assisted autonomous closed reduction or traditional experience-based manual closed reduction, both followed by conventional proximal femoral intramedullary nailing internal fixation.

Receive post-operative low-dose CT scans before discharge or within 2 weeks after surgery to evaluate the fracture reduction quality.

Follow a standardized Enhanced Recovery After Surgery (ERAS) rehabilitation pathway and attend scheduled follow-up visits at 1, 3, and 6 months after the surgery to monitor bone healing, hip functions, and quality of life

Conditions

• Intertrochanteric Fractures
• Intertrochanteric Fractures of the Hip
• Intertrochanteric Fractures of the Femur

Interventions

PROCEDURE

Robot-assisted closed reduction and internal fixation

The key distinguishing feature of this intervention is the transition from empirical, experience-based traction to computer-planned, quantitatively-controlled reduction. The robotic system creates an individualized 3D model based on pre-operative thin-layer CT and automatically calculates precise fragment displacement parameters. Unlike manual methods, the reduction pathway is executed or guided via real-time spatial navigation and digital monitoring with strict safety interlocking mechanisms. This approach aims to reduce human judgment bias and enhance 3D anatomical alignment precision, particularly in correcting complex translation and rotational deformities.

PROCEDURE

Conventional manual closed reduction and internal fixation

This intervention relies entirely on the surgical team's clinical experience, using a standard orthopedic traction table or manual manipulation to achieve bone alignment. Unlike the experimental group, no intelligent robotic systems, 2D-3D registration software, or spatial tracking devices are permitted during any stage of the operation. Reduction quality is evaluated intraoperatively using routine two-dimensional C-arm fluoroscopy (AP and lateral views) rather than computerized 3D planning. If closed alignment is inadequate, the surgeon may convert to a limited open reduction using joysticks or clamps based on empirical judgment.

Sponsors & Collaborators

• Beihang University

  collaborator OTHER

• Aerospace Center Hospital

  collaborator OTHER

• Beijing Jishuitan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-12-29

Completion

2028-12-29

Countries

• China

Study Locations