Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss

Assiut University

Status: Not yet enrolling

Conditions: Open Fracture Tibia

Treatments: Procedure: intramedullary nail with Limb Reconstruction System

Study type: Interventional

Funder types: Other

Identifiers

NCT05296785

17200694

Details and patient eligibility

About

Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age from 18-60 years old.
• Open Grade II, Open Grade III (a & b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
• Bone defect < 10 cm.
• Patients with Injury severity score (ISS) < 17.

Exclusion criteria

• Massive bone defect > 10 cm.
• Patients with ISS > 17, polytrauma patient.
• Age < 18 years old or > 60 years old.
• Associated vascular injury ischemic limb.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Participants

Other group

Description:

patients undergoes intramedullary nail with Limb Reconstruction System

Treatment:

Procedure: intramedullary nail with Limb Reconstruction System