- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05884827
Peroneal Nerve Dysfunction in Epiphyseal Transfer
Peroneal Nerve Dysfunction in Proximal Fibular Epiphyseal Harvesting Cases
Study Overview
Detailed Description
In children the preserved epiphysis of the proximal fibula ensure the exceptional ability to recover both joint function and longitudinal limb growth at the same time. Traumatic bone defect, congenital malformations, malignant bone lesions and infection are all current indications for VFET. The shape and size of the proximal fibular epiphysis aid in the gradual remodeling of the articular surface, allowing for better reconstruction and eventual rehabilitation over time.
Harvesting the proximal epiphysis of the fibula, along with its intact blood supply, is technically demanding, and the success of VFET is a primarily dependent on restoring adequate vascularity to the growth plate and diaphysis.
Anterior tibial artery is the primary and most consistent contributor to the proximal fibular epiphysis and proximal two thirds of diaphysis, it has intimate connection to the motor (deep) branch of peroneal nerve. The success of anterior tibial artery based VFET based on preserving the anterior tibial Vascular bundle, so it may be necessary to sacrifice some branches of peroneal nerve to tibialis anterior muscle. This is a significant flaw in the approach that could result in permanent peroneal nerve palsy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Moustafa Elsese, Resident
- Phone Number: 01009246781
- Email: Ahmedelsese@med.aun.edu.eg
Study Contact Backup
- Name: Omar Ahmed Refai, Consultant
- Phone Number: 01003412298
- Email: Omarrefai@med.aun.edu.eg
Study Locations
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-
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Assiut, Egypt, 71511
- Recruiting
- Omar
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Contact:
- Omar Ahmed Refai, Consultant
- Phone Number: 01003412298
- Email: Omarrefai@med.aun.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- all patients candidate for epiphyseal transfer are included ( patients with traumatic bone defect, congenital malformations, malignant bone lesions and infection )
Exclusion Criteria:
- patients in which there's no injury of nerve supply of tibialis anterior has occurred intraoperative
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Tibialis anterior dysfunction after proximal fibular epiphyseal harvesting
Time Frame: Six months
|
Electromyography changes at 3 weeks , 6 weeks , 3 months and 6 months to assess the affection of tibialis anterior muscle & peroneal nerve
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Six months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Grimer RJ. Surgical options for children with osteosarcoma. Lancet Oncol. 2005 Feb;6(2):85-92. doi: 10.1016/S1470-2045(05)01734-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EMG in Epiphyseal transfer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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