Distal Tibial FractureNCT07733271
Robot-Assisted Closed Reduction and Internal Fixation for Extra-Articular Distal Tibial Fractures
A study testing Robot-assisted closed reduction and Traditional surgeon-led reduction in people with Distal Tibial Fracture and Tibial Fractures, run by Beijing Jishuitan Hospital at 2 sites in China.
Trial summary
This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Distal Tibial Fracture, Tibial Fractures
- What is being tested?
- Robot-assisted closed reduction and Traditional surgeon-led reduction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2026to 31 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
- Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-A)
- Time from injury to surgery < 21 days
- Able to walk independently before injury (assistive devices allowed)
Who cannot join
- Open fractures or multiple severe traumas requiring priority treatment
- Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation/length evaluation
- Ipsilateral fractures combined with other sites
- Pathological fractures (tumor/metabolic)
- Prior complex implants in place or previous surgeries significantly affecting evaluation
- Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery)
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- Cognitive impairment, poor compliance, pregnancy, or lactation
- Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury)
- Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/enrollment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Aerospace Center Hospital
Beijing, Beijing Municipality, 100035
Yonghui Liang, MD / Chief Physician
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035
Chunpeng Zhao, MD / Chief Physician, +86 18610012704, zcpllza2008@163.com
About this study
Official title: Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)
This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
- Conditions
- Distal Tibial Fracture, Tibial Fractures
- Being tested
- Robot-assisted closed reduction, Traditional surgeon-led reduction
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted closed reductionDevice
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, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique.
Traditional surgeon-led reductionProcedure or surgery
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 tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Group | Experimental | Not described Receives: Device: Robot-assisted closed reduction |
| Traditional Group | Active comparator | Not described Receives: Procedure: Traditional surgeon-led 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
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:
- Separation/shortening displacement: Excellent (≤3mm), Good (>3-5mm), Fair (>5-10mm), Poor (>10mm).
- Angulation deformity: Excellent (≤3°), Good (>3-5°), Fair (>5-10°), Poor (>10°).
- 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.
Measured: 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
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
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
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
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
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
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
Foot and Ankle Ability Measure-Activities of Daily Living Score
The Foot and Ankle Ability Measure-Activities of Daily Living (FAAM-ADL) score is used to assess the functional status of patients with foot and ankle disorders. The subscale consists of 21 items, with a maximum total raw score of 84. The scores are converted into a percentage score ranging from 0% to 100%, where a higher score indicates a higher level of functional ability.
Measured: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
Lower Extremity Functional Scale Score
The Lower Extremity Functional Scale (LEFS) is used to evaluate the patient's lower extremity function and ability to perform everyday tasks. The scale contains 20 items with a total raw score ranging from 0 to 80, where a higher score represents better functional status.
Measured: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol 5-Dimension 5-Level Health Index
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire evaluates health-related quality of life across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw response is converted into a health state index score typically ranging from 0 (representing death) to 1 (representing perfect health), with higher scores reflecting better overall quality of life.
Measured: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol Visual Analogue Scale Score
The EuroQol Visual Analogue Scale (EQ VAS) provides a quantitative measure of the patient's self-rated overall health status. The score is recorded on a visual scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: From baseline to 1 month, 3 months, 6 months and 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Tibial FractureStudies 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
- Aerospace Center Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733271
- Sponsor's protocol ID
- Ji-Lun [K2026] No. [190]-00
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Technology Research and Development for Intelligent Minimally Invasive Precision Treatment of Fractures (Sub-project 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)
- ClinicalTrials.gov ID
- NCT07733271
- Acronym / sponsor ID
- Ji-Lun [K2026] No. [190]-00
- Conditions
- Distal Tibial Fracture, Tibial Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Collaborators
- Aerospace Center Hospital
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 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.
This study aims to evaluate the clinical efficacy and safety of an intelligent fracture reduction robot system in treating extra-articular distal tibial fractures. Traditional manual bone setting depends heavily on a surgeon's experience, which can sometimes lead to inconsistent alignment and increased radiation exposure. This clinical trial compares robot-assisted closed reduction against the traditional surgeon-led method. The primary goal is to determine if the robotic system improves the rate of accurate fracture alignment (excellent and good reduction rate) and helps patients recover better.
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 Group | Experimental | Device: Robot-assisted closed reduction |
| Traditional Group | Active comparator | Procedure: Traditional surgeon-led reduction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-A)
- Time from injury to surgery < 21 days
- Able to walk independently before injury (assistive devices allowed)
Key exclusion criteria (9 listed)
- Open fractures or multiple severe traumas requiring priority treatment
- Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation/length evaluation
- Ipsilateral fractures combined with other sites
- Pathological fractures (tumor/metabolic)
- Prior complex implants in place or previous surgeries significantly affecting evaluation
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 reductionThe 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, the fracture is fixed with a distal tibial locking plate via the minimally invasive percutaneous plate osteosynthesis (MIPO) technique. | Device | Robot-Assisted Group |
| Traditional surgeon-led reductionThe 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 tibial locking plates or intramedullary nails according to the surgeon's choice and standard of care. | Procedure or surgery | Traditional Group |
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
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.
14 secondary outcomes
Total Operation Time Measured in Minutes
Time frame: From initial skin incision to completion of skin closure, assessed up to 8 hours
Number of Intraoperative C-Arm Fluoroscopy Shots
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
Length of Hospital Stay Measured in Days
Time frame: 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
Time frame: From initial skin incision to completion of the reduction maneuver, assessed up to 8 hours
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
Foot and Ankle Ability Measure-Activities of Daily Living Score
Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
Lower Extremity Functional Scale Score
Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol 5-Dimension 5-Level Health Index
Time frame: From baseline to 1 month, 3 months, 6 months and 12 months after surgery
EuroQol Visual Analogue Scale Score
Time frame: From baseline to 1 month, 3 months, 6 months and 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
Incidence of Reoperation
Time frame: From completion of surgery to reoperation 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 29 Jul 2026.
- 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.
2 sites 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 Traditional surgeon-led reduction in people with Distal Tibial Fracture and Tibial Fractures, run by Beijing Jishuitan Hospital at 2 sites 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 3 inclusion and 9 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 29 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 2 sites 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, MD / Chief Physician (+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 29 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.