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A clinical randomized controlled study of closed reduction and minimally invasive internal fixation versus open reduction and internal fixation of bone plates in the treatment of ankle fractures

A clinical randomized controlled study of closed reduction and minimally invasive internal fixation versus open reduction and internal fixation of bone plates in the treatment of ankle fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096352
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Ankle Fractures

Interventions

Minimally Invasive Reduction and Internal Fixation Group:Closed reduction and internal fixation with Kirschner wires or cannulated screws for ankle fracture patients.
Open Reduction and Internal Fixation Group:Patients with ankle fractures undergo open reduction and internal fixation treatment.

Sponsors

Wendeng Orthopedic Hospital, Shandong Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, gender is not limited. 2. Confirmed diagnosis of ankle fracture (Weber B or Weber type C, with or without medial malleolus fracture). 3. The case is suitable for CRIF or ORIF treatment. 4. Patients voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of previous ankle surgery or severe ankle degenerative changes. 2. Severe medical diseases (such as uncontrolled diabetes mellitus, renal insufficiency). 3. Concomitant infectious diseases or other contraindications to surgery. 4. Combined with vascular nerve injury. 5. Patients who cannot be followed up regularly as required

Design outcomes

Primary

MeasureTime frame
Ankle Joint Function Score (using the AOFA score).;Incidence of Complications;

Secondary

MeasureTime frame
Fracture Healing Time;Reduction Quality (assessed using the Burwell & Charnley score);Postoperative VAS (Visual Analog Scale) scores (at 3 days, 7 days, 1 month, 3 months).;Surgical-related parameters (e.g., surgical time, intraoperative blood loss, hospital stay duration, costs).;Quality of Life Score (using the SF-36 scale or EQ-5D questionnaire);

Countries

China

Contacts

Public ContactJunwei Zhang

Wendeng Orthopedic Hospital, Shandong Province

15806314586@163.com+86 158 0631 4586

Outcome results

None listed

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