NCT06324916

Brief Summary

This study was carried out at Assiut University to Asses the long-term donor site morbidity following free vascularized fibular transfer because there is a limited information regarding the long-term donor morbidity of this type of flap.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jan 2024

Typical duration for all trials

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

Study Progress78%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

September 21, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

September 21, 2023

Last Update Submit

March 15, 2024

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

  • Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system

    in the point evaluation system patients filled out a questionnaire about the donor site scar, function loss, wound healing, complications, and pain. A total morbidity score was developed based on these items using a point rating system.

    Two years after surgery

Interventions

XrayRADIATION

X rays for ankle to see distal fibular remenant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a Retrospective Cohort study based on Assiut University microsurgery unit our target is All eligible patients during the period of the study will be included (total coverage sample). Expected number according to patients flow in the last year is 20 patients in Assiut University orthopedic surgery hospitals.

You may qualify if:

  • Patients done FVFG for reconstruction of bone defect other than lower limb bone defect.
  • surgery done \>2yrs
  • Patient age \> 18 yrs old

You may not qualify if:

  • Patient age \< 18 Surgery done\< 2yrs FVFG for reconstruction of lower limb bone defct Amputated other leg : Above Ankle Amputaion Double FVFG Fracture of the other leg side : Fracture Tibia, Fibula, Ankle Paraplegic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (13)

  • Taylor GI, Miller GD, Ham FJ. The free vascularized bone graft. A clinical extension of microvascular techniques. Plast Reconstr Surg. 1975 May;55(5):533-44. doi: 10.1097/00006534-197505000-00002.

    PMID: 1096183BACKGROUND

  • Weinert CR Jr, McMaster JH, Ferguson RJ. Dynamic function of the human fibula. Am J Anat. 1973 Oct;138(2):145-9. doi: 10.1002/aja.1001380202. No abstract available.

    PMID: 4747734BACKGROUND

  • Skraba JS, Greenwald AS. The role of the interosseous membrane on tibiofibular weightbearing. Foot Ankle. 1984 May-Jun;4(6):301-4. doi: 10.1177/107110078400400605.

    PMID: 6735287BACKGROUND

  • Lee EH, Goh JC, Helm R, Pho RW. Donor site morbidity following resection of the fibula. J Bone Joint Surg Br. 1990 Jan;72(1):129-31. doi: 10.1302/0301-620X.72B1.2298771.

    PMID: 2298771BACKGROUND

  • Babhulkar SS, Pande KC, Babhulkar S. Ankle instability after fibular resection. J Bone Joint Surg Br. 1995 Mar;77(2):258-61.

    PMID: 7706342BACKGROUND

  • Loro A, Hodges A, Galiwango GW, Loro F. Vascularized fibula flap in the management of segmental bone loss following osteomyelitis in children at a Ugandan hospital. J Bone Jt Infect. 2021 May 25;6(6):179-187. doi: 10.5194/jbji-6-179-2021. eCollection 2021.

    PMID: 34109102BACKGROUND

  • Kanaya K, Wada T, Kura H, Yamashita T, Usui M, Ishii S. Valgus deformity of the ankle following harvesting of a vascularized fibular graft in children. J Reconstr Microsurg. 2002 Feb;18(2):91-6. doi: 10.1055/s-2002-19888.

    PMID: 11823939BACKGROUND

  • Shingade VU, Jagtap SM, Ranade AB. Weakness of extensor hallucis longus after removal of non-vascularised fibula as an autograft. J Bone Joint Surg Br. 2004 Apr;86(3):384-7. doi: 10.1302/0301-620x.86b3.14748.

    PMID: 15125126BACKGROUND

  • Di Giuli R, Zago M, Beltramini GA, Pallotta ML, Bolzoni A, Baj A, Gianni AB, Sforza C. Donor-Site Morbidity After Osteocutaneous Free Fibula Transfer: Longitudinal Analysis of Gait Performance. J Oral Maxillofac Surg. 2019 Mar;77(3):648-657. doi: 10.1016/j.joms.2018.10.016. Epub 2018 Nov 2.

    PMID: 30481496BACKGROUND

  • Hakim SG, Tehrany AS, Wendlandt R, Jacobsen HC, Trenkle T, Sieg P. The impact of harvest length and detachment of the interosseous membrane on donor-site morbidity following free fibula flap surgery-a biomechanical experimental study. J Craniomaxillofac Surg. 2018 Nov;46(11):1939-1942. doi: 10.1016/j.jcms.2018.09.003. Epub 2018 Sep 19.

    PMID: 30309796BACKGROUND

  • Zimmermann CE, Borner BI, Hasse A, Sieg P. Donor site morbidity after microvascular fibula transfer. Clin Oral Investig. 2001 Dec;5(4):214-9. doi: 10.1007/s00784-001-0140-5.

    PMID: 11800433BACKGROUND

  • Hadouiri N, Feuvrier D, Pauchot J, Decavel P, Sagawa Y. Donor site morbidity after vascularized fibula free flap: gait analysis during prolonged walk conditions. Int J Oral Maxillofac Surg. 2018 Mar;47(3):309-315. doi: 10.1016/j.ijom.2017.10.006.

    PMID: 29100670BACKGROUND

  • Goyal T, Paul S, Choudhury AK, Sethy SS. Full-thickness peroneus longus tendon autograft for anterior cruciate reconstruction in multi-ligament injury and revision cases: outcomes and donor site morbidity. Eur J Orthop Surg Traumatol. 2023 Jan;33(1):21-27. doi: 10.1007/s00590-021-03145-3. Epub 2021 Oct 26.

    PMID: 34698925BACKGROUND

MeSH Terms

Conditions

Osteosarcoma

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Central Study Contacts

Hedra Rafat Ishak

CONTACT

00201069557727hedra.rafat@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

September 21, 2023

First Posted

March 22, 2024

Study Start

January 10, 2024

Primary Completion

January 10, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

EG(1)