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Clinical study on the treatment of fracture of middle and lower segment of tibia with curved needle and semi-annular external fixator

Clinical study on the treatment of fracture of middle and lower segment of tibia with curved needle and semi-annular external fixator

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060449
Enrollment
Unknown
Registered
2022-06-01
Start date
2022-05-22
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Fracture of the middle and lower tibia

Interventions

The treatment group:The bent needle is fitted with a semi-annular external fixator
The control group:Closed reduction plate screw internal fixation

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 60 years; 2. Type AO-42B fracture that meets the above diagnostic criteria for middle and lower tibial fractures; 3. Fresh and untreated fractures; 4. The subjects understood the risks of treatment methods related to tibial fracture (splint, plaster, external fixator, plate, intramedullary nail), independently chose treatment methods and voluntarily signed informed consent; 5. The function of the affected limb was basically normal before injury, and the affected limb had no previous history of fracture or orthopedic surgery; 6. After informing the patient of the surgical plan and risk, the subject understands and accepts it and can follow up regularly.

Exclusion criteria

Exclusion criteria: 1. Patients with pathological fracture or old fracture of tibia; 2. Special fracture conditions, such as: tibial pseudojoint, bone tumor, secretory or metabolic bone disease, etc.; 3. Patients suffering from serious underlying diseases or severe organ injuries caused by trauma, which affect the results; 4. Pregnant patients and lactating patients; 5. Patients with poor compliance or who cannot bear anesthesia due to underlying diseases.

Design outcomes

Primary

MeasureTime frame
Johner-Wruhs scoring criteria;

Countries

China

Contacts

Public ContactShi Changlong

Wangjing Hospital, China Academy of Chinese Medical Sciences

shichanglong126@126.com+86 13911287611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026