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Key Technology Development for Intelligent Minimally Invasive Precise Treatment of Fractures (Subtopic 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)

Key Technology Development for Intelligent Minimally Invasive Precise Treatment of Fractures (Subtopic 4: A Randomized Controlled Trial of Robot-Assisted Closed Reduction and Internal Fixation for Distal Tibial Fractures)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124359
Enrollment
Unknown
Registered
2026-05-11
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal tibial fracture

Interventions

Trial group:The closed reduction of fractures is autonomously completed by robots, and the internal fixation operation is carried out by the surgeon.

Sponsors

Beijing Jishuitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 80 years old, gender not limited; 2. Diagnosed as unilateral, acute, closed distal tibial fracture (AO/OTA 43-A); 3. No more than 21 days from injury to surgery; 4. Before the injury, the individual could walk independently (assistive devices are allowed).

Exclusion criteria

Exclusion criteria: 1. Open fractures or multiple severe traumas that require priority treatment; 2. Asymmetry of both lower extremities or previous malunion of the ipsilateral femoral shaft or previous malformations that significantly affect rotation/length assessment; 3. Unilateral fractures combined with fractures in other parts; 4. Pathological fractures (tumor/metabolic); 5. Previous complex implants on the same side or previous surgeries have a significant impact on the assessment; 6. Active infection or severe systemic internal medical contraindications (inability to tolerate anesthesia/surgery); 7. Cognitive impairment/Poor compliance/Pregnancy or lactation; 8. Those who are not suitable for enrollment as determined by the researchers (such as those who cannot be followed up as planned or have poor local soft tissue conditions, such as obvious blisters, etc.); 9. Refuse randomization or refusal to enroll.

Design outcomes

Primary

MeasureTime frame
The excellent and good rate of closed reduction;

Secondary

MeasureTime frame
Fracture healing rate;EQ-5D-5L;HHS Score;

Countries

China

Contacts

Public ContactZhao Chunpeng

Beijing Jishuitan Hospital, Capital Medical University

Zcpllza2008@163.com+86 186 1001 2704

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026