Results of Cross-leg Free Vascularized Fibular Graft

Not yet recruiting

• Conditions: Tibial Fractures

• Registration Number: NCT06491316
• Lead Sponsor: Assiut University

Brief Summary

This study aims to evaluate the new technique of cross-leg vascularized fibular graft for reconstruction of post-traumatic long tibial bone defects in terms of restoring normal anatomy and function of the traumatized limb in a series of cases admitted in Assiut University hospital, Orthopedics and trauma surgery department.

Detailed Description

Reconstruction of post-traumatic long tibial bone defects is still a major therapeutic challenge faced by orthopaedic surgeons on both anatomical and functional concerns, and it is usually associated with significant long-term morbidity. Historically, Amputation was the treatment of choice for long tibial bone defects because of difficulty of reconstructove management of such cases. Over the last few decades, Limb salvage procedures have been developed. During the second world war, massive cancellous bone autograft has been the preferred treatment. But traditional bone graft procedures in many cases may be limited by uncontrollable graft resorption. To overcome this disadvantage different management options have been developed to address bone defects of various lengths as vascularized fibular grafts, Ilizarov technique using bifocal or trifocal bone transport, acute limb shortening and masquelet procedure. However, In some cases long bone defects are associated with extensive soft tissue lacerations together with poor ipsilateral blood supply. For those cases previous surgical options are associated with many complications and may end up with failure of reconstruction and amputation, in this situation cross-leg vascularized fibular graft may be a good treatment option because it can provide a blood supply away from that of the extensively traumatized limb.

Study Timeline

• Study First Submitted: 2023-03-20
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-30
• Last Update Submitted: 2024-06-30
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Study Start: 2024-07-20
• Primary Completion: 2024-08-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients who were admitted into Assiut University Hospital, Orthopedics and Trauma Surgery department with big tibial bone defects ranging from 12 cm to 26 cm, associated with extensive soft tissue damage and poor ipsilateral blood supply confirmed by CT angiography and treated with cross-leg free vascularized fibular graft.

Exclusion Criteria

• Patients with bilateral extensive soft tissue damage and poor blood supply.
• Patients with medical conditions preventing them from general anesthesia for long periods (>10 hours).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of cases of Flap survival	6 weeks from operation	Flap intake and vascularization without necrosis
Number of cases of Bone healing	1 year from operation	Radiological evaluation

Secondary Outcome Measures

Name	Time	Method
Number of cases with accepted Limb alignment	1 year	Long film x-ray of both lower limbs to assess bone alignment

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt