Skip to content

The comparison of clinical effects among different methods in the treatment of syndesmotic injuries in malleolar fractures

The comparison of clinical effects among different methods in the treatment of syndesmotic injuries in malleolar fractures

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029937
Enrollment
Unknown
Registered
2020-02-16
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

Malleolar Fractures

Interventions

Screw Fixation Group:Screw fixation to treat lower tibiofibular syndesmotic injuries
Elastic Fixation Group:Elastic fixation to treat lower tibiofibular syndesmotic injuries
Direct Repair Group:Direct repair to treat lower tibiofibular syndesmotic injuries
Early Screw Removement Group:Remove the screw of patients in screw fixation group within 6 weeks after the operation
Mid-term Screw Removement Group:Remove the screw of patients in screw fixation group between 6 weeks to 12 weeks after the operation
Late Screw Removement Group:Remove the screw of patients in screw fixation group more than 12 weeks after the operation
Preoperative Diagnosis Group:Diagnose the ankle fracture with lower tibiofibular syndesmosis injury according to the preoperative imaging
Intraoperative Validation Group:Review surgical records and postoperative images to determine if there are tibiofibular syndesmosis injuries

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients of ankle fractures who were admitted and operated by our hospital from 2014 to 2016; 2. The preoperative imaging examinations were consistent with the diagnostic criteria of lower tibiofibular syndesmosis injury; 3. Those >= 16 years old; 4, Medical history information is well documented.

Exclusion criteria

Exclusion criteria: 1. Previous orthopaedic operation history of the affected side; 2. History of systemic arthritis around the affected ankle; 3. History of soft tissue injury to the affected ankle within 6 months before the operation; 4. Multiple fractures of the affected side.

Design outcomes

Primary

MeasureTime frame
Specificity of imaging diagnosis of lower tibiofibular syndesmosis injury;Sensitivity of imaging diagnosis of lower tibiofibular syndesmosis injury;Postoperative imaging evaluation of lower tibiofibular syndesmosis injury;Postoperative clinical function score of lower tibiofibular syndesmosis injury;

Secondary

MeasureTime frame
Postoperative complications;Incidence of revision surgery;

Countries

China

Contacts

Public ContactYukai Wang

Trauma Service III, Sixth Floor, Orthopaedic Building, Shanghai Sixth People's Hospital

Duncanjams@126.com+86 18930174381

Outcome results

None listed

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