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Recruiting NCT06324916

Donor Site Morbidity After Free Vascularized Fibular Graft

Observational Osteosarcoma

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xray.
Who it may be relevant to
Registry conditions: Osteosarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system [Time frame: Two years after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut university — Asyut

Publications

  • 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 1096183
  • 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 4747734
  • 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 6735287
  • 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 2298771
  • Babhulkar SS, Pande KC, Babhulkar S. Ankle instability after fibular resection. J Bone Joint Surg Br. 1995 Mar;77(2):258-61. PMID 7706342
  • 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 34109102
  • 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 11823939
  • 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 15125126

Identifiers

NCT: NCT06324916 · vascularized fibular graft

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗