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Tibial FracturesNCT06491316

Results of Cross-leg Free Vascularized Fibular Graft

An observational study of Tibial Fractures, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Tibial Fractures
How many people
22 participants
Where
1 siteEgypt
Study dates
20 Jul 2024to 30 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Mahmoud M Saad, MBBCh contact

00201060039941 ext. 0020882340431

Mahmoud.20134331@med.aun.edu.eg

Omar A Refai, Lecturer contact

00201003412298

omarrefai@aun.edu.eg

Egypt1 site

  • Assiut University Hospital

    Asyut, 71515

    Amr E Ali, Professor, 00201099021770, Amr.elsayed@med.aun.edu.eg

Other trials in Egypt

About this study

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

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.

Keywords
Cross-leg flap, Vascularized fibular transfer, Open grade III tibial fractures
Medical subject headings
Tibial Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of cases of Flap survival

    Flap intake and vascularization without necrosis

    Measured: 6 weeks from operation

  2. Number of cases of Bone healing

    Radiological evaluation

    Measured: 1 year from operation

Secondary outcomes (1)

  1. Number of cases with accepted Limb alignment

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start20 Jul 2024 (estimated)
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491316
Sponsor's protocol ID
Results of Cross-leg FVFG
Status last verified
Jun 2024
First submitted
20 Mar 2023
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Tibial Fractures, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud M Saad, MBBCh (00201060039941 ext. 0020882340431, Mahmoud.20134331@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of cases of Flap survival (time frame: 6 weeks from operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06491316, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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