Femoral Shaft FracturesNCT07738380
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
A study testing Robot-Assisted Closed Reduction and Conventional Closed Reduction in people with Femoral Shaft Fractures and Femur Fractures, run by Beijing Jishuitan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femoral Shaft Fractures, Femur Fractures, Femur Fracture
- What is being tested?
- Robot-Assisted Closed Reduction and Conventional Closed Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 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.
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Unable to complete the planned follow-up period.
- Refusal to undergo randomization.
- Refusal to participate in the clinical study.
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, zcpllza2008@163.com
About this study
Official title: Robot-Assisted Versus Traditional Closed Reduction and Internal Fixation for Femoral Shaft Fractures: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Robot-Assisted Closed Reduction, Conventional Closed Reduction
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Closed ReductionProcedure or surgery
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.
Conventional Closed ReductionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Closed Reduction |
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 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.
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 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.
Measured: From initial skin incision to completion of skin closure, assessed up to 8 hours
Change from Baseline in Lower Extremity Functional Scale Score (LEFS)
Lower extremity function will be evaluated using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items concerning activities of daily living, each scored from 0 to 4 (0=extreme difficulty/unable to perform; 4=no difficulty). The total score ranges from 0 to 80 points; higher scores indicate better functional ability.
Measured: 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)
Health-related quality of life will be evaluated using the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L). It assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores are converted into an index value, where higher values indicate a better quality of life.
Measured: From baseline to 1 month, 3 months, 6 months, and 12 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.
Time Frame:
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 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 12 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
Time to Radiographic Fracture Union Assessed by Standard X-Ray
Time to radiographic fracture union will be measured in weeks using standard anteroposterior and lateral X-rays. Fracture union is defined as cortical bridging in at least 3 of 4 cortices with no significant pain during weight-bearing. 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 12 months after surgery
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 12 months after surgery
Incidence of Intraoperative Complications
The percentage of participants experiencing intraoperative complications, including neurovascular injury, cortical perforation, abnormal bleeding, device failure, registration failure requiring manual takeover or change of reduction strategy, 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 wound problems or infection, thrombotic events, internal fixation failure, or loss of reduction, will be recorded.
Measured: From completion of surgery to postoperative complication assessment, assessed up to 12 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.
- Other trials for Femoral Shaft 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
- 80 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
- NCT07738380
- Sponsor's protocol ID
- Ji-Lun [K2026] No. 188-00
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 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
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 Versus Traditional Closed Reduction and Internal Fixation for Femoral Shaft Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738380
- Acronym / sponsor ID
- Ji-Lun [K2026] No. 188-00
- Conditions
- Femoral Shaft Fractures, Femur Fractures, Femur Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 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 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.
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 Close Reduction | Experimental | Procedure: Robot-Assisted Closed ReductionPatients in this arm will undergo autonomous closed reduction of the fracture assisted by a robotic system, followed by internal fixation performed by the surgeon. |
| Traditional Close Reduction | Active comparator | Procedure: Conventional Closed ReductionPatients in this arm will undergo traditional closed reduction (or open reduction if necessary) performed manually by the surgeon, followed by conventional internal fixation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 ReductionPatients 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. | Procedure or surgery | Robot-Assisted Close Reduction |
| Conventional Closed ReductionPatients 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. | Procedure or surgery | Traditional Close 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 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.
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 Lower Extremity Functional Scale Score (LEFS)
Time frame: 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)
Time frame: From baseline to 1 month, 3 months, 6 months, and 12 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 Reoperation
Time frame: From completion of surgery to reoperation assessment, assessed up to 12 months after surgery
Length of Hospital Stay Measured in Days
Time frame: From hospital admission to hospital discharge, assessed up to 30 days
Time to Radiographic Fracture Union Assessed by Standard X-Ray
Time frame: From completion of surgery to the first documented radiographic evidence of fracture union, assessed up to 12 months after surgery
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 12 months after surgery
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 postoperative complication assessment, assessed up to 12 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.
- Individual participant dataSharing planned: No
Related trials for Femoral Shaft Fractures
Not yet recruiting
Rehabilitation After Lower Extremity Nailing Trial
Femoral Shaft Fracture, Tibial Shaft Fractures
Not yet recruiting
Feasibility of Structured Resistance Training After Lower Extremity Fracture
Lower Extremity Fractures
Recruiting
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
Femoral Fracture
Recruiting
Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia Fractures
Not yet recruiting
Fixation of Shaft Femure Fracrture by Ender Versus Plate
Shaft Femure Fracture in Adolescents
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 Conventional Closed Reduction in people with Femoral Shaft Fractures and Femur Fractures, 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 6 inclusion and 18 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?
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.