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Clinical Trials/NCT06491316
NCT06491316
Not yet recruiting
Not Applicable

Long Term Results of Cross-leg Free Vascularized Fibular Transfer for Reconstruction of Complex Post-traumatic Tibial Bone Defects: a Case Series Study

Assiut University1 site in 1 country22 target enrollmentJuly 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tibial Fractures
Sponsor
Assiut University
Enrollment
22
Locations
1
Primary Endpoint
Number of cases of Flap survival
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2024
End Date
October 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Mohammad Saad

Demonstrator at Orthopedics and Trauma surgery department, Assiut university hospital

Assiut University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Number of cases of Flap survival

Time Frame: 6 weeks from operation

Flap intake and vascularization without necrosis

Number of cases of Bone healing

Time Frame: 1 year from operation

Radiological evaluation

Secondary Outcomes

  • Number of cases with accepted Limb alignment(1 year)

Study Sites (1)

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