Donor Site Morbidity After Free Vascularized Fibular Graft

Osteosarcoma Clinical Trial

Official title:

Long Term Evaluation Of Donor Site Morbidities After Free Vascularized Fibular Graft For Reconstruction Of Any Bone Defect Other Than In The Lower Limb

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324916
• Other study ID #: vascularized fibular graft
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Hedra Rafat Ishak
• Phone: 00201069557727
• Email: hedra.rafat[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

There is a dearth of information on the long-term donor site morbility of free fibular flaps. The recipient site can influence outcomes in the majority of research on donor site morbidity of free fibular grafting, but in this study, The invistigators will assess donor site morbidity and contrast the donor Leg with the contralateral Healthy one.

Surgical method for free fibular flapTo reduce ankle instability, the fibula was removed through lateral approach while the distal 5-7 cm of the bone was preserved. To seal the wound at the donor location, a full thickness or split thickness skin graft may be required. a suction drain that is implanted prior to healing. The donor leg was tightly covered with a bandage below the knee once the wound was closed. Using a skin graft to seal the wound.A gel foam pressure pack will be placed on top of an occlusive dressing if a skin transplant was utilized to seal the wound..

postoperative patients management: There was no difference in the postoperative care given to patients who had skin grafts at the donor location versus those who did not.

The entries in the patients' charts were used to evaluate postoperative wound healing at the donor site. It was determined whether wound healing was simple or involved. Dehiscence of wounds, necrosis of soft tissues,Patients will be questioned about when they first started using crutches and when they stopped using them after surgery, as well as when their ambulation returned to normal.

They were questioned about their subjective current symptoms of discomfort, pain, and edema, as well as about temperature differences, sensory abnormalities, motor function (i.e., range of motion), their ability to walk, run, ride a bike, and climb stairs, limitations on daily activities, and their satisfaction with the donor leg's scar's appearance.

During the physical examination in researchs, the donor leg was compared to the unoperated leg for the following parameters: strength and stability (ability to stand and walk on tiptoe and heels with both legs, with the unoperated and the operated leg); and sensory evaluation in specific areas of the calf. The latter included standardized examinations of pressure and touch perception (with a standardized pressure probe and cotton swab, respectively),the big toe was most frequently involved with weakness, both in flexion and extension. The muscle stripping of EHL and FHL during the harvest of the fibula is probably responsible for the weakness.

In this study,the invistigators will assess the outcomes and conduct data analysis to assess donor site morbidity and the benefits of surgery after free vascularized fibular transfer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2026
• Est. primary completion date: January 10, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients done FVFG for reconstruction of bone defect other than lower limb bone defect.

• surgery done >2yrs

• Patient age > 18 yrs old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Radiation:
• Xray
X rays for ankle to see distal fibular remenant

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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