Donor Site Morbidity After Free Vascularized Fibular Graft

March 15, 2024 updated by: Hedra Rafat Abdallah Ishak, Assiut University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system
Time Frame: Two years after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

March 15, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vascularized fibular graft

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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