NCT07738380 Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
| NCT ID | NCT07738380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Jishuitan Hospital |
| Condition | Femoral Shaft Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-12-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-07-01 with a primary completion date of 2028-12-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria： * 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. Exclusion Criteria： * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07738380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Femoral Shaft Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738380 currently recruiting?
Yes, NCT07738380 is actively recruiting participants. Contact the research team at zcpllza2008@163.com for enrollment information.
Where is the NCT07738380 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07738380 clinical trial?
NCT07738380 is sponsored by Beijing Jishuitan Hospital. The trial plans to enroll 80 participants.