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The study for the biomechanical characteristics and clinical treatment effect of the supporting fixation in the tension side of Pilon fractures

The study for the biomechanical characteristics and clinical treatment effect of the supporting fixation in the tension side of Pilon fractures

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027877
Enrollment
Unknown
Registered
2019-12-01
Start date
2020-12-31
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Pilon Fracture

Interventions

Experimental group:Additional medial supporting fixation
The control group:anterolateral plate fixation only

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with valgus Pilon fracture aged 18-65 years, regardless of gender; 2. Definition of Pilon valgus: violent injury of the patient valgus, and the force line shown on the positive X-ray is the deformity of tibia and fibula valgus. 3. No other factors affecting the postoperative evaluation of femoral neck fracture, such as trauma; 4. ASA anesthesia risk I- III level, the systemic state tolerated operation risk.

Exclusion criteria

Exclusion criteria: 1. Patients with bilateral fractures in the same place, or injuries to the opposite side; 2. Patients with fractures on either side of the lower extremity in the past 6 months (including the current); 3. Patients with a history of malignant tumor, radiotherapy and pathological fracture; 4. Patients under the age of 18 or over the age of 65, pregnant or preparing to be pregnant or nursing women; 5. Patients who have participated in other clinical trials within the past two months; 6. Suffering from Parkinson's disease (disease) severe enough to increase the possibility of falling or endanger the rehabilitation, thyroid dysfunction, six months have suffered from acute myocardial infarction, cerebrovascular accident, serious trauma or major surgery after the patient, with mental illness or poor compliance; 7. Long-term use of non-steroidal drugs, fluoroquinolones antibiotics, antiplatelet drugs and other drugs patients; 8. Patients with chronic alcoholism.

Design outcomes

Primary

MeasureTime frame
AP X-ray;Ankle AOFAS scale;

Secondary

MeasureTime frame
EQ-5D scale;SF-36 scale;

Countries

China

Contacts

Public ContactZhu Yi

Shanghai Sixth People's Hospital

tzjzzy@163.com+86 18930170625

Outcome results

None listed

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