NCT06491316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

July 9, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

March 20, 2023

Last Update Submit

June 30, 2024

Conditions

Tibial Fractures

Keywords

Cross-leg flapVascularized fibular transferOpen grade III tibial fractures

Outcome Measures

Primary Outcomes (2)

  • Number of cases of Flap survival

    Flap intake and vascularization without necrosis

    6 weeks from operation

  • Number of cases of Bone healing

    Radiological evaluation

    1 year from operation

Secondary Outcomes (1)

  • Number of cases with accepted Limb alignment

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (7)

  • Watson JT, Anders M, Moed BR. Management strategies for bone loss in tibial shaft fractures. Clin Orthop Relat Res. 1995 Jun;(315):138-52.

    PMID: 7634662BACKGROUND

  • 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.

    PMID: 458883BACKGROUND

  • 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.

    PMID: 29290472BACKGROUND

  • 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.

    PMID: 7927661BACKGROUND

  • 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.

    PMID: 28408083BACKGROUND

  • 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.

    PMID: 30700126BACKGROUND

  • 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.

    PMID: 29129017BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Central Study Contacts

Mahmoud M Saad, MBBCh

CONTACT

00201060039941Mahmoud.20134331@med.aun.edu.eg

Omar A Refai, Lecturer

CONTACT

00201003412298omarrefai@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at Orthopedics and Trauma surgery department, Assiut university hospital

Study Record Dates

First Submitted

March 20, 2023

First Posted

July 9, 2024

Study Start

July 20, 2024

Primary Completion

August 30, 2024

Study Completion

October 30, 2024

Last Updated

July 9, 2024

Record last verified: 2024-06

Locations

EG(1)