Intertrochanteric FracturesNCT07738458
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
A study testing Robot-assisted closed reduction and internal fixation and Conventional manual closed reduction and internal fixation in people with Intertrochanteric Fractures and Intertrochanteric Fractures of the Hip, run by Beijing Jishuitan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip, Intertrochanteric Fractures of the Femur
- What is being tested?
- Robot-assisted closed reduction and internal fixation and Conventional manual closed reduction and internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 29 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Other condition that prevents compliance with postoperative follow-up or rehabilitation protocols.
- Current participation in another clinical trial that may interfere with evaluation of this study's outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Chunpeng Zhao, +86 18610012704, 2987566589@qq.com
About this study
Official title: Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Robot-assisted closed reduction and internal fixation, Conventional manual closed reduction and internal fixation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted closed reduction and internal fixationProcedure or surgery
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.
Conventional manual closed reduction and internal fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional manual closed reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Total operation time will be measured in minutes and defined as the duration from the initial skin incision to completion of skin closure.
Measured: From initial skin incision to completion of skin closure, assessed up to 8 hours
Intraoperative Blood Loss Measured in Milliliters
The estimated total volume of blood loss during the surgical procedure will be recorded in milliliters (mL).
Measured: 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)
Hip function will be evaluated using the Harris Hip Score (HHS). The score ranges from 0 to 100 points, evaluating domains including pain, daily functions (gait, activities of daily living), absence of deformity, and joint range of motion. A higher score indicates better hip function and lower pain severity.
Measured: 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
Health-related quality of life will be evaluated using the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L). It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Descriptive scores are converted into a standard index value, where higher values mean better health status.
Measured: From baseline to 1 month, 3 months, and 6 months after surgery
Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray
Time to radiographic bone healing will be measured in weeks. Radiographic bone healing will be defined as cortical bridging in at least 3 of 4 cortices on standard anteroposterior and lateral X-rays, with no significant pain during weight-bearing. Low-dose CT may be used to confirm bone healing in uncertain cases.
Measured: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Number of Intraoperative C-Arm Fluoroscopy Shots
The number of intraoperative fluoroscopy shots taken using the C-arm during the surgical procedure will be recorded.
Measured: From initial skin incision to completion of skin closure, assessed up to 8 hours
Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group
For participants assigned to the experimental group, the robot-assisted reduction planning and execution time will be recorded in minutes. This time is defined as the duration from completion of robotic arm setup to completion of the reduction maneuver.
Measured: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
Incidence of Intraoperative Complications
The percentage of participants experiencing intraoperative complications, including neurovascular injury, device failure, or conversion to manual reduction, will be recorded.
Measured: From initial skin incision to completion of skin closure, assessed up to 8 hours
Incidence of Postoperative Complications
The percentage of participants experiencing postoperative complications, including surgical site infection, deep vein thrombosis, implant loosening or breakage, screw cut-out, or femoral head collapse, will be recorded.
Measured: From completion of surgery to the occurrence of postoperative complications, assessed up to 6 months after surgery
Length of Hospital Stay Measured in Days
The length of hospital stay will be recorded in days from admission to hospital discharge.
Measured: From hospital admission to hospital discharge, assessed up to 30 days
Radiographic Fracture Union Rate Assessed by Standard X-Ray
The percentage of participants achieving radiographic fracture union will be assessed using standard anteroposterior and lateral X-rays. Low-dose CT may be used to confirm fracture union in uncertain cases.
Measured: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Incidence of Reoperation
The percentage of participants requiring reoperation after the index surgery will be recorded.
Measured: From completion of surgery to reoperation assessment, assessed up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Jul 2026
- Primary completion29 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intertrochanteric FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University, Aerospace Center Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738458
- Sponsor's protocol ID
- Jilun [K2026] No. [187]-00
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29699731Graulich 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.
PubMed 40217650Baumgaertner 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.
PubMed 7608228Chang 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.
PubMed 25840887Liu 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.
PubMed 32828132Zhao 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.
PubMed 31359265Kou 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.
PubMed 38077454Bai 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.
PubMed 31426577Zhao 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.
PubMed 35379278Cho 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.
PubMed 30152606Zhao 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.
PubMed 36471345Zhao 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.
PubMed 36371315Zhao 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.
PubMed 39534853
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738458
- Acronym / sponsor ID
- Jilun [K2026] No. [187]-00
- Conditions
- Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip, Intertrochanteric Fractures of the Femur
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Beihang University, Aerospace Center Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 29 Dec 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Closed Reduction | Experimental | Procedure: Robot-assisted closed reduction and internal fixationParticipants 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. |
| Traditional Manual Closed Reduction | Active comparator | Procedure: Conventional manual closed reduction and internal fixationPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted closed reduction and internal fixationThe 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 or surgery | Robot-Assisted Closed Reduction |
| Conventional manual closed reduction and internal fixationThis 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. | Procedure or surgery | Traditional Manual Closed Reduction |
Primary outcome
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria
Time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery
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.
12 secondary outcomes
Total Operation Time Measured in Minutes
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Intraoperative Blood Loss Measured in Milliliters
Time frame: 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)
Time frame: 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
Time frame: From baseline to 1 month, 3 months, and 6 months after surgery
Time to Radiographic Bone Healing Assessed by Standard Two-View X-Ray
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Number of Intraoperative C-Arm Fluoroscopy Shots
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Robot-Assisted Reduction Planning and Execution Time Measured in Minutes in the Experimental Group
Time frame: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
Incidence of Intraoperative Complications
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Incidence of Postoperative Complications
Time frame: From completion of surgery to the occurrence of postoperative complications, assessed up to 6 months after surgery
Length of Hospital Stay Measured in Days
Time frame: From hospital admission to hospital discharge, assessed up to 30 days
Radiographic Fracture Union Rate Assessed by Standard X-Ray
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 6 months after surgery
Incidence of Reoperation
Time frame: From completion of surgery to reoperation assessment, assessed up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 29699731Veronese 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.
- Background: PubMed 40217650Graulich 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.
- Background: PubMed 7608228Baumgaertner 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.
- Background: PubMed 25840887Chang 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.
- Background: PubMed 32828132Liu 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.
- Background: PubMed 31359265Zhao 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.
- Background: PubMed 38077454Kou 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.
- Background: PubMed 31426577Bai 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.
- Background: PubMed 35379278Zhao 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.
- Background: PubMed 30152606Cho 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.
- Background: PubMed 36471345Zhao 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.
- Background: PubMed 36371315Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted closed reduction and internal fixation and Conventional manual closed reduction and internal fixation in people with Intertrochanteric Fractures and Intertrochanteric Fractures of the Hip, run by Beijing Jishuitan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunpeng Zhao (+86 18610012704, zcpllza2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Excellent or Good Closed Fracture Reduction Assessed by Postoperative Low-Dose CT-Based 3D Quantitative Reduction Grading Criteria (time frame: From completion of surgery to postoperative low-dose CT assessment, assessed up to 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738458, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.