OsteosarcomaNCT06324916
Donor Site Morbidity After Free Vascularized Fibular Graft
An observational study of Osteosarcoma, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Xray
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients done FVFG for reconstruction of bone defect other than lower limb bone defect.
- surgery done >2yrs
- Patient age > 18 yrs old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Osteosarcoma
- Being tested
- Xray
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XrayRadiation
X rays for ankle to see distal fibular remenant
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Jan 2024
- Primary completion10 Jan 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hedra Rafat Abdallah Ishak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324916
- Sponsor's protocol ID
- vascularized fibular graft
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 1096183Weinert 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.
PubMed 4747734Skraba 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.
PubMed 6735287Lee 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.
PubMed 2298771Babhulkar SS, Pande KC, Babhulkar S. Ankle instability after fibular resection. J Bone Joint Surg Br. 1995 Mar;77(2):258-61.
PubMed 7706342Loro 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.
PubMed 34109102Kanaya 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.
PubMed 11823939Shingade 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.
PubMed 15125126Di 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.
PubMed 30481496Hakim 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.
PubMed 30309796Zimmermann 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.
PubMed 11800433Hadouiri 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.
PubMed 29100670Goyal 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.
PubMed 34698925
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06324916
- Acronym / sponsor ID
- vascularized fibular graft
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 10 Jan 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients done FVFG for reconstruction of bone defect other than lower limb bone defect.
- surgery done >2yrs
- Patient age > 18 yrs old
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XrayX rays for ankle to see distal fibular remenant | Radiation | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 1096183Taylor 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.
- Background: PubMed 4747734Weinert 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.
- Background: PubMed 6735287Skraba 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.
- Background: PubMed 2298771Lee 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.
- Background: PubMed 7706342Babhulkar SS, Pande KC, Babhulkar S. Ankle instability after fibular resection. J Bone Joint Surg Br. 1995 Mar;77(2):258-61.
- Background: PubMed 34109102Loro 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.
- Background: PubMed 11823939Kanaya 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.
- Background: PubMed 15125126Shingade 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.
- Background: PubMed 30481496Di 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.
- Background: PubMed 30309796Hakim 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.
- Background: PubMed 11800433Zimmermann 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.
- Background: PubMed 29100670Hadouiri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hedra Rafat Ishak (00201069557727, hedra.rafat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor site morbidity in contrast with surgery benifits this will be measured by point evaluation system (time frame: Two years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324916, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.