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The efficacy and safety of small incision open reduction and intramedullary nail fixation surgery in the treatment of simple tibial shaft fracture

The efficacy and safety of small incision open reduction and intramedullary nail fixation surgery in the treatment of simple tibial shaft fracture

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051290
Enrollment
Unknown
Registered
2021-09-18
Start date
2019-01-01
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

tibial shaft fracture

Interventions

experimental group:small incision open reduction
control group:closed reduction

Sponsors

Ninghai First Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 63 Years

Inclusion criteria

Inclusion criteria: 1. Patients with simple tibial shaft fractures (Type A, B and C1, C2 according to the AO classification); 2. Normal cardiopulmonary function and stable hemodynamics.

Exclusion criteria

Exclusion criteria: 1. Complicated with open injury involved the operation area; 2. Ipsilateral knee and ankle joint injury and/or fracture displacement that affecting the operation method; 3. Patients with refractory severe hypertension (>180/110mmHg); patients with refractory blood sugar> 13.9mmol/L; patients with severe cardiopulmonary, liver and kidney insufficiency; patients with systemic diseases and immunodeficiency; patients with severe malnutrition or conditions unsuitable for surgery; patients with infection, bacteremia, and/or sepsis; other conditions which might render the patient intolerable for surgery; 4. Patients with severe osteoporosis that affect the stability of intramedullary nail fixation; 5. Patients who refused to participate the study; 6. Patients with severe mental illness or other cognitive disorders that might seriously affect postoperative functional evaluation; 7. Patients with pathological fractures.

Design outcomes

Primary

MeasureTime frame
operation time;bleeding volume;clinical efficacy;postoperative complications;

Countries

China

Contacts

Public ContactChen Shi

Department of Orthopedic, Ninghai Medical Center First Hospital

chenshi65536811@126.com+86 15867588383

Outcome results

None listed

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