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

NCT07738458 | Recruiting

• 1 other identifier: Jilun [K2026] No. [187]-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

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 low-dose CT using a 3D quantitative grading system. Four dimensions will be graded as Excellent, Good, Fair, or Poor: displacement/shortening, angular deformity, rotational deformity, and medial/anterior cortical support. The thresholds are ≤3 mm/° for Excellent, \>3-5 mm/° for Good, \>5-10 mm/° for Fair, and \>10 mm/° for Poor, while cortical support is graded as positive, neutral, mild negative, or significant negative/step-off. The final grade will be the lowest grade across all 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 Hip Function Assessed by Harris Hip Score (HHS)

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

• Change from Baseline in Quality of Life Assessed by EQ-5D-5L Questionnaire

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

• Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray

  From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery

Study Arms (2)

Robot-Assisted Closed Reduction

EXPERIMENTAL

Participants will undergo robot-assisted closed reduction followed by conventional proximal femoral intramedullary nailing internal fixation, using the Robot-Assisted Fracture Reduction (RAFR) system. The robotic system will identify bone fragment displacement parameters based on pre-operative 3D CT images, plan the optimal reduction pathway, and execute or assist the surgeon in performing the closed reduction under real-time navigation and safety control. After reduction, a standard proximal femoral intramedullary nail will be implanted using routine minimally invasive surgical techniques to achieve stable internal fixation.

Procedure: Robot-assisted closed reduction and internal fixation

Traditional Manual Closed Reduction

ACTIVE COMPARATOR

Patients assigned to this arm will undergo traditional manual closed reduction of the intertrochanteric femoral fracture . The reduction will be executed by the surgeon using conventional traction and manual manipulation under standard fluoroscopic guidance. Following manual closed reduction, conventional proximal femoral intramedullary nailing internal fixation will be performed by the surgeon.

Procedure: Conventional manual closed reduction and internal fixation

Interventions

Robot-assisted closed reduction and internal fixation PROCEDURE

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.

Robot-Assisted Closed Reduction

Conventional manual closed reduction and internal fixation PROCEDURE

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.

Traditional Manual Closed 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.
• Male or female participants.
• Acute, closed intertrochanteric femoral fracture.
• AO/OTA classification 31-A intertrochanteric femoral fracture.
• Fracture requiring closed reduction and proximal femoral intramedullary nailing.
• Injury-to-surgery interval no more than 14 days.
• Participant or legally authorized representative is fully informed about the study.
• Written informed consent voluntarily provided by the participant or legally authorized representative.

You may not qualify if:

• Open fracture.
• Pathological fracture.
• Old fracture with an injury-to-surgery interval greater than 14 days.
• Multiple fractures.
• Previous surgery involving the affected hip joint.
• Deformity of the affected hip joint.
• Severe osteoarthritis of the affected hip joint.
• Significant neuromuscular disease affecting lower limb function.
• Significant neuromuscular disease affecting postoperative rehabilitation.
• Severe systemic comorbidity that makes the participant unable to tolerate anesthesia or surgery.
• Severe organ dysfunction that makes the participant unable to tolerate anesthesia or surgery.
• Pregnancy.
• Lactation.
• Cognitive impairment that prevents compliance with postoperative follow-up or rehabilitation protocols.
• Active psychiatric illness that prevents compliance with postoperative follow-up or rehabilitation protocols.

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

Related Publications (13)

• Veronese N, Maggi S. Epidemiology and social costs of hip fracture. Injury. 2018 Aug;49(8):1458-1460. doi: 10.1016/j.injury.2018.04.015. Epub 2018 Apr 20.

  PMID: 29699731 BACKGROUND

• Graulich T, Omar M, Sehmisch S, Liodakis E. Controversies in the Treatment Strategies of Intertrochanteric Fractures: A Scoping Review and Discussion of a Literature-Based Algorithm. J Clin Med. 2025 Mar 24;14(7):2200. doi: 10.3390/jcm14072200.

  PMID: 40217650 BACKGROUND

• Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995 Jul;77(7):1058-64. doi: 10.2106/00004623-199507000-00012.

  PMID: 7608228 BACKGROUND

• Chang SM, Zhang YQ, Ma Z, Li Q, Dargel J, Eysel P. Fracture reduction with positive medial cortical support: a key element in stability reconstruction for the unstable pertrochanteric hip fractures. Arch Orthop Trauma Surg. 2015 Jun;135(6):811-8. doi: 10.1007/s00402-015-2206-x. Epub 2015 Apr 4.

  PMID: 25840887 BACKGROUND

• Liu P, Jin D, Zhang C, Gao Y. Revision surgery due to failed internal fixation of intertrochanteric femoral fracture: current state-of-the-art. BMC Musculoskelet Disord. 2020 Aug 22;21(1):573. doi: 10.1186/s12891-020-03593-8.

  PMID: 32828132 BACKGROUND

• Zhao JX, Li C, Ren H, Hao M, Zhang LC, Tang PF. Evolution and Current Applications of Robot-Assisted Fracture Reduction: A Comprehensive Review. Ann Biomed Eng. 2020 Jan;48(1):203-224. doi: 10.1007/s10439-019-02332-y. Epub 2019 Jul 29.

  PMID: 31359265 BACKGROUND

• Kou W, Zhou P, Lin J, Kuang S, Sun L. Technologies evolution in robot-assisted fracture reduction systems: a comprehensive review. Front Robot AI. 2023 Nov 22;10:1315250. doi: 10.3389/frobt.2023.1315250. eCollection 2023.

  PMID: 38077454 BACKGROUND

• Bai L, Yang J, Chen X, Sun Y, Li X. Medical Robotics in Bone Fracture Reduction Surgery: A Review. Sensors (Basel). 2019 Aug 18;19(16):3593. doi: 10.3390/s19163593.

  PMID: 31426577 BACKGROUND

• Zhao C, Wang Y, Wu X, Zhu G, Shi S. Design and evaluation of an intelligent reduction robot system for the minimally invasive reduction in pelvic fractures. J Orthop Surg Res. 2022 Apr 4;17(1):205. doi: 10.1186/s13018-022-03089-2.

  PMID: 35379278 BACKGROUND

• Cho YC, Lee PY, Lee CH, Chen CH, Lin YM. Three-dimensional CT Improves the Reproducibility of Stability Evaluation for Intertrochanteric Fractures. Orthop Surg. 2018 Aug;10(3):212-217. doi: 10.1111/os.12396.

  PMID: 30152606 BACKGROUND

• Zhao C, Zhu G, Wang Y, Wu X. TiRobot-assisted versus conventional fluoroscopy-assisted percutaneous sacroiliac screw fixation for pelvic ring injuries: a meta-analysis. J Orthop Surg Res. 2022 Dec 5;17(1):525. doi: 10.1186/s13018-022-03420-x.

  PMID: 36471345 BACKGROUND

• Zhao C, Cao Q, Sun X, Wu X, Zhu G, Wang Y. Intelligent robot-assisted minimally invasive reduction system for reduction of unstable pelvic fractures. Injury. 2023 Feb;54(2):604-614. doi: 10.1016/j.injury.2022.11.001. Epub 2022 Nov 4.

  PMID: 36371315 BACKGROUND

• Zhao C, Xiao H, Cao Q, Ge Y, Li Y, Wang Y, Zhu G, Wu X. Innovative development of robot reduction system in geriatric pelvic fractures: A single-center case series in Beijing, China. J Orthop Translat. 2024 Oct 30;49:283-288. doi: 10.1016/j.jot.2024.08.023. eCollection 2024 Nov.

  PMID: 39534853 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

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: June 29, 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)