NCT07738406 Robot-Assisted Closed Reduction and Internal Fixation for Distal Femoral Fractures
| NCT ID | NCT07738406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Jishuitan Hospital |
| Condition | Supracondylar Femoral Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-12-31 |
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 2027-12-31.
⚠ 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
This study aims to evaluate the clinical efficacy and safety of an intelligent robotic system for the closed reduction of extra-articular supracondylar femoral fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A). Traditional manual reduction for supracondylar femoral fractures is often challenging due to strong muscle pull, heavily relying on the surgeon's experience and frequently requiring repeated fluoroscopy. This clinical trial compares robot-assisted closed reduction against traditional surgeon-led reduction methods. The primary goal is to determine if the robotic system improves the precision of bone alignment (excellent and good reduction rate) and functional recovery while reducing surgical radiation exposure.
Eligibility Criteria
Inclusion Criteria: * Age between 18 and 80 years old * Unilateral, acute, closed extra-articular supracondylar femoral fracture (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 33-A) * Time from injury to surgery ≤21 days * Able to walk independently before injury (assistive devices allowed) Exclusion Criteria: * Open fractures or multiple severe traumas requiring priority treatment * Asymmetrical lower extremities, or prior malunion of the ipsilateral femur, or pre-existing deformities significantly affecting rotation/length evaluation * Unilateral fractures combined with other sites * Pathological fractures (tumor or metabolic) * Prior complex implants in place or previous surgeries significantly affecting evaluation * Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery) * Cognitive impairment, poor compliance, pregnancy, or lactation * Deemed unsuitable by the investigator (e.g., unable to follow up, or extreme obesity severely limiting the surgical or robotic workspace) * Refused randomization or enrollment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07738406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Supracondylar Femoral Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738406 currently recruiting?
Yes, NCT07738406 is actively recruiting participants. Contact the research team at zcpllza2008@163.com for enrollment information.
Where is the NCT07738406 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07738406 clinical trial?
NCT07738406 is sponsored by Beijing Jishuitan Hospital. The trial plans to enroll 80 participants.