NCT05884827

Brief Summary

Assessment of peroneal nerve dysfunction after proximal fibular epiphyseal resection and evaluation of clinical outcome and EMG changes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
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

April 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

April 23, 2023

Last Update Submit

February 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of Tibialis anterior dysfunction after proximal fibular epiphyseal harvesting

    Electromyography changes at 3 weeks , 6 weeks , 3 months and 6 months to assess the affection of tibialis anterior muscle \& peroneal nerve

    Six months

Interventions

EMGDEVICE

Measure the electrical activity of the muscle and nerve

Eligibility Criteria

Age18 Months - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with destroyed epiphysis whatever the cause of destruction and with preserved proximal fibular epiphysis

You may qualify if:

  • all patients candidate for epiphyseal transfer are included ( patients with traumatic bone defect, congenital malformations, malignant bone lesions and infection )

You may not qualify if:

  • patients in which there's no injury of nerve supply of tibialis anterior has occurred intraoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar

Asyut, 71511, Egypt

RECRUITING

Related Publications (6)

  • Zelenski N, Brigman BE, Levin LS, Erdmann D, Eward WC. The vascularized fibular graft in the pediatric upper extremity: a durable, biological solution to large oncologic defects. Sarcoma. 2013;2013:321201. doi: 10.1155/2013/321201. Epub 2013 Oct 7.

    PMID: 24222724BACKGROUND
  • Shammas RL, Avashia YJ, Farjat AE, Catanzano AA, Levin LS, Eward WC, Brigman BE, Erdmann D. Vascularized Fibula-Based Physis Transfer: A Follow-Up Study of Longitudinal Bone Growth and Complications. Plast Reconstr Surg Glob Open. 2017 May 25;5(5):e1352. doi: 10.1097/GOX.0000000000001352. eCollection 2017 May.

    PMID: 28607872BACKGROUND
  • Ghert M, Colterjohn N, Manfrini M. The use of free vascularized fibular grafts in skeletal reconstruction for bone tumors in children. J Am Acad Orthop Surg. 2007 Oct;15(10):577-87. doi: 10.5435/00124635-200710000-00001.

    PMID: 17916780BACKGROUND
  • Innocenti M, Delcroix L, Romano GF. Epiphyseal transplant: harvesting technique of the proximal fibula based on the anterior tibial artery. Microsurgery. 2005;25(4):284-92. doi: 10.1002/micr.20130.

    PMID: 15934045BACKGROUND
  • Sales de Gauzy J, Accadbled F, Gomez Brouchet A, Abid A. Case report: histologic study of a human epiphyseal transplant at 3 years after implantation. Clin Orthop Relat Res. 2009 Jul;467(7):1915-20. doi: 10.1007/s11999-009-0723-z. Epub 2009 Feb 11.

    PMID: 19212796BACKGROUND
  • Grimer RJ. Surgical options for children with osteosarcoma. Lancet Oncol. 2005 Feb;6(2):85-92. doi: 10.1016/S1470-2045(05)01734-1.

    PMID: 15683817BACKGROUND

Central Study Contacts

Ahmed Moustafa Elsese, Resident

CONTACT

Omar Ahmed Refai, Consultant

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 23, 2023

First Posted

June 1, 2023

Study Start

June 1, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations