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Effects of early versus delayed weight-bearing on postoperative outcomes after retrograde tibial intramedullary nail in the treatment of extra-articular distal tibial fractures (AO/OTA43A): a randomized, controlled, study

Effects of early versus delayed weight-bearing on postoperative outcomes after retrograde tibial intramedullary nail in the treatment of extra-articular distal tibial fractures (AO/OTA43A): a randomized, controlled, study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094487
Enrollment
Unknown
Registered
2024-12-24
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Extra-articular distal tibial fractures (AO/OTA43A)

Interventions

Sponsors

Dongnan Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged = 18 years with mature epiphyseal development; 2.Fractures classified as OA/OTA 43A and tibial fracture line proximal to the plafond within 4 cm to 11 cm; 3.Patients are willing and able to comply with the planning, rehabilitation, nursing, and follow-up protocols of this study.

Exclusion criteria

Exclusion criteria: 1.Patients under the age of 18 with underdeveloped epiphyseal plates; 2.Patients who cannot tolerate surgery due to important organ damage or have other surgical contraindications and cannot undergo surgery; 3.Pathological or old fractures of the distal tibia; 4.Ipsilateral fractures of the proximal tibia or tibial shaft; 5.Patients with open tibial fractures requiring nerve and vascular repair; 6.Mental disorder or any mental disorder that affects the patient's behavior; 7.Local skin or soft tissue defects or infections; 8.Medical or psychological disorders that hinder functional testing (severe traumatic brain injury, stroke, heart disease, etc.).

Design outcomes

Primary

MeasureTime frame
AOFAS ankle - hind foot function score;EuroQol 5-dimensions-5-levels;Bone Union;

Secondary

MeasureTime frame
Implant failure ;Infection;Implant stimulation;

Countries

China

Contacts

Public ContactWu Jin

Dongnan Hospital of Xiamen University

wujin1983@xmu.edu.cn+86 134 5962 9903

Outcome results

None listed

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