CClinicalTrials.gg
Not yet recruitingNCT06491316Updated Jul 9, 2024

Results of Cross-leg Free Vascularized Fibular Graft

An observational study in Tibial Fractures, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
22
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tibial Fractures

Browse trials for

Keywords

  • Cross-leg flap
  • Vascularized fibular transfer
  • Open grade III tibial fractures
03

In context

Tibial Fractures

159 studies on the registry are indexed under Tibial Fractures; 40 are open to participants now.

This study's planned enrollment of 22 is below the median of 83 across 46 observational studies indexed under Tibial Fractures.

Browse Tibial Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
22 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Number of cases of Flap survival

    Flap intake and vascularization without necrosis

    Time frame: 6 weeks from operation

  2. Number of cases of Bone healing

    Radiological evaluation

    Time frame: 1 year from operation

Secondary outcomes

  1. Number of cases with accepted Limb alignment

    Long film x-ray of both lower limbs to assess bone alignment

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Publications

  • Watson JT, Anders M, Moed BR. Management strategies for bone loss in tibial shaft fractures. Clin Orthop Relat Res. 1995 Jun;(315):138-52. PubMed 7634662 ↗
  • Weinberg H, Roth VG, Robin GC, Floman Y. Early fibular bypass procedures (tibiofibular synostosis) for massive bone loss in war injuries. J Trauma. 1979 Mar;19(3):177-81. doi: 10.1097/00005373-197903000-00008. PubMed 458883 ↗
  • Wu Y, Yin Q, Rui Y, Sun Z, Gu S. Ilizarov technique: Bone transport versus bone shortening-lengthening for tibial bone and soft-tissue defects. J Orthop Sci. 2018 Mar;23(2):341-345. doi: 10.1016/j.jos.2017.12.002. Epub 2017 Dec 28. PubMed 29290472 ↗
  • Hertel R, Gerber A, Schlegel U, Cordey J, Ruegsegger P, Rahn BA. Cancellous bone graft for skeletal reconstruction. Muscular versus periosteal bed--preliminary report. Injury. 1994;25 Suppl 1:A59-70. doi: 10.1016/0020-1383(94)90263-1. PubMed 7927661 ↗
  • 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. PubMed 28408083 ↗
  • Catagni MA, Azzam W, Guerreschi F, Lovisetti L, Poli P, Khan MS, Di Giacomo LM. Trifocal versus bifocal bone transport in treatment of long segmental tibial bone defects. Bone Joint J. 2019 Feb;101-B(2):162-169. doi: 10.1302/0301-620X.101B2.BJJ-2018-0340.R2. PubMed 30700126 ↗
  • Zhang Y, Wang Y, Di J, Peng A. Double-level bone transport for large post-traumatic tibial bone defects: a single centre experience of sixteen cases. Int Orthop. 2018 May;42(5):1157-1164. doi: 10.1007/s00264-017-3684-y. Epub 2017 Nov 11. PubMed 29129017 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06491316
Lead sponsor
Assiut University
Responsible party
Mahmoud Mohammad Saad (Demonstrator at Orthopedics and Trauma surgery department, Assiut university hospital, Assiut University) — Principal investigator
First posted
Jul 9, 2024
Start date
Jul 20, 2024 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Oct 30, 2024 (estimated)
Last update
Jul 9, 2024

Study contacts

Mahmoud M Saad, MBBCh
Contact
Mahmoud.20134331@med.aun.edu.eg
00201060039941 ext. 0020882340431
Omar A Refai, Lecturer
Contact
omarrefai@aun.edu.eg
00201003412298

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion