Clinical trial NCT06491316: Results of Cross-leg Free Vascularized Fibular Graft
Official title: Long Term Results of Cross-leg Free Vascularized Fibular Transfer for Reconstruction of Complex Post-traumatic Tibial Bone Defects: a Case Series Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tibial Fractures
Keywords: Cross-leg flap
Vascularized fibular transfer
Open grade III tibial fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases who were presented to 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 and are presented recently for achieving long term results assessment.

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.

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).

Primary outcomes:
measure: Number of cases of Flap survival
timeFrame: 6 weeks from operation
measure: Number of cases of Bone healing
timeFrame: 1 year from operation
Secondary outcomes:
measure: Number of cases with accepted Limb alignment
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
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citation: Tong K, Zhong Z, Peng Y, Lin C, Cao S, Yang Y, Wang G. Masquelet technique versus Ilizarov bone transport for reconstruction of lower extremity bone defects following posttraumatic osteomyelitis. Injury. 2017 Jul;48(7):1616-1622. doi: 10.1016/j.injury.2017.03.042. Epub 2017 Apr 4.
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