Bone NeoplasmNCT03129672
Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
An observational study of Bone Neoplasm, run by Patricia Bonilla at 1 site in Panama.
Trial summary
The study show the clinical results of limb salvage for primary malignant bone tumor of the distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis with different methods of fixation (plates or intramedullary nail system) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Neoplasm
- What is being tested?
- allograft arthrodesis of ankle
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 sitePanama
- Study dates
- 20 May 2014to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients that were diagnosis with primary malignant bone tumor of the distal tibia and went trough resection and reconstruction with allograft
Who may be able to join
- all patients with histopathologyc diagnosis of a primary malignant bone tumor at the distal tibia that went through a tumor resection and received reconstruction with allograft as first surgical treatment
Who cannot join
- none histopatologic proved diagnosis
- patients that received other kind of surgical treatment
Trial locations and contacts
1 site in 1 country.
Panama1 site, 1 recruiting
- Recruiting
Panama Children Hospital
Panama City, 0823
patricia bonilla, MD, +507-5129813 ext. 150, patibh_8@hotmail.com
Jorge Navia, MD, +57-3155643400, jorgenaviagiraldo@gmail.com
About this study
The study show the clinical results of limb salvage for primary malignant bone tumor of the distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis with different methods of fixation (plates or intramedullary nail system)
Read the detailed description
It is well known that before the 1980's the usual treatment for the sarcomas of the distal tibia was amputation (1). Currently, however, after the improvement of the chemotherapy treatments, potential reconstructions of the area in well studied patients are possible, and for that we have a wide range: auto graft, allograft and prosthetic reconstructions (2, 3)
Is important to know that osteosarcoma still meant the principal diagnosis, followed by the Ewing sarcoma and synovial sarcoma, but their malignant potency is lower than when they are present in the rest of the body (4, 5, and 6)
The purpose of this study is to recollect the patients' data followed from different institutions and countries that have the criteria for their inclusion in the study (primary malignant bone tumor of the distal tibia that underwent block excision of the tumor and reconstruction with allograft arthrodesis from the patient management for any of the multidisciplinary sarcoma team including in this study).
- Conditions
- Bone Neoplasm
- Being tested
- allograft arthrodesis of ankle
- Keywords
- allograft, distal tibia sarcoma
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allograft arthrodesis of ankleProcedure or surgery
patients that underwent trought a block resection of a malignant tumor of the distal tibia and reconstruction with allograft arthrodesis
What is being measured
The primary outcome is the main question the study is designed to answer.
principal diagnosis of the patients that wen trough ankle after resection of a primary malignant tumor of the distal tibia
osteosarcoma: 5 patientas (2 females of 18 and 15 years old and 3 males of 19, 24 and 16 years old) telangiectasic osteosarcoma (1 female of 21 years old) Ewing sarcoma (1 male of 33 years old)
Measured: 1 month
Secondary outcomes (3)
mobility
surgical site infection, non union, malunion, osteosynthesis material failure
Measured: 5 month to 10 years follow up
mortality
secundary of the primary tumor diagnosis or metastatic disease of it
Measured: 5 months to 10 years follow up
MSTS SCORE
total points score of the msts score at the final follow up
Measured: 5 month to 10 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start20 May 2014
- Primary completion1 Jun 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patricia Bonilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Niño "Dr. José Renán Esquivel"
- Responsible party
- Sponsor-investigator, Patricia Bonilla, Hospital del Niño "Dr. José Renán Esquivel"
- Investigators
- patricia bonilla, MD, Principal investigator, Hospital del Niño
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129672
- Sponsor's protocol ID
- 000001
- Status last verified
- Feb 2019
- First submitted
- 13 Oct 2015
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Burrows HJ, Wilson JN, Scales JT. Excision of tumours of humerus and femur, with restoration by internal prostheses. J Bone Joint Surg Br. 1975 May;57(2):148-59.
PubMed 1141281Ebeid W, Amin S, Abdelmegid A, Refaat Y, Ghoneimy A. Reconstruction of distal tibial defects following resection of malignant tumours by pedicled vascularised fibular grafts. Acta Orthop Belg. 2007 Jun;73(3):354-9.
PubMed 17715726Liu T, Guo X, Zhang X, Li Z, Zhang Q. Reconstruction with pasteurized autograft for primary malignant bone tumor of distal tibia. Bull Cancer. 2012 Sep;99(9):87-91. doi: 10.1684/bdc.2012.1626.
PubMed 22863837Ruggieri P, Angelini A, Jorge FD, Maraldi M, Giannini S. Review of foot tumors seen in a university tumor institute. J Foot Ankle Surg. 2014 May-Jun;53(3):282-5. doi: 10.1053/j.jfas.2014.01.015.
PubMed 24751209Azevedo CP, Casanova JM, Guerra MG, Santos AL, Portela MI, Tavares PF. Tumors of the foot and ankle: a single-institution experience. J Foot Ankle Surg. 2013 Mar-Apr;52(2):147-52. doi: 10.1053/j.jfas.2012.12.004. Epub 2013 Jan 16.
PubMed 23333280Zeytoonjian T, Mankin HJ, Gebhardt MC, Hornicek FJ. Distal lower extremity sarcomas: frequency of occurrence and patient survival rate. Foot Ankle Int. 2004 May;25(5):325-30. doi: 10.1177/107110070402500509.
PubMed 15134614Clayer M, Doyle S, Sangha N, Grimer R. The toronto extremity salvage score in unoperated controls: an age, gender, and country comparison. Sarcoma. 2012;2012:717213. doi: 10.1155/2012/717213. Epub 2012 Sep 13.
PubMed 23028240Ozger H, Eralp L, Turker M, Basaran M. Surgical treatment of malignant tumors of the foot and ankle. Int J Clin Oncol. 2005 Apr;10(2):127-32. doi: 10.1007/s10147-004-0470-9.
PubMed 15864699Enneking WF, Dunham W, Gebhardt MC, Malawar M, Pritchard DJ. A system for the functional evaluation of reconstructive procedures after surgical treatment of tumors of the musculoskeletal system. Clin Orthop Relat Res. 1993 Jan;(286):241-6.
PubMed 8425352
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
- ClinicalTrials.gov ID
- NCT03129672
- Acronym / sponsor ID
- 000001
- Conditions
- Bone Neoplasm
- Keywords
- allograft, distal tibia sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Patricia BonillaUniversity, hospital or other
- Collaborators
- Hospital del Niño "Dr. José Renán Esquivel"
- Study start
- 20 May 2014 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 26 Apr 2017 (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.
The study show the clinical results of limb salvage for primary malignant bone tumor of the distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis with different methods of fixation (plates or intramedullary nail system)
Detailed description
It is well known that before the 1980's the usual treatment for the sarcomas of the distal tibia was amputation (1). Currently, however, after the improvement of the chemotherapy treatments, potential reconstructions of the area in well studied patients are possible, and for that we have a wide range: auto graft, allograft and prosthetic reconstructions (2, 3)
Is important to know that osteosarcoma still meant the principal diagnosis, followed by the Ewing sarcoma and synovial sarcoma, but their malignant potency is lower than when they are present in the rest of the body (4, 5, and 6)
The purpose of this study is to recollect the patients' data followed from different institutions and countries that have the criteria for their inclusion in the study (primary malignant bone tumor of the distal tibia that underwent block excision of the tumor and reconstruction with allograft arthrodesis from the patient management for any of the multidisciplinary sarcoma team including in this study).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients that were diagnosis with primary malignant bone tumor of the distal tibia and went trough resection and reconstruction with allograft
Key inclusion criteria (1 listed)
- all patients with histopathologyc diagnosis of a primary malignant bone tumor at the distal tibia that went through a tumor resection and received reconstruction with allograft as first surgical treatment
Key exclusion criteria (2 listed)
- none histopatologic proved diagnosis
- patients that received other kind of surgical treatment
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 |
|---|---|---|
| allograft arthrodesis of anklepatients that underwent trought a block resection of a malignant tumor of the distal tibia and reconstruction with allograft arthrodesis | Procedure or surgery | – |
Primary outcome
principal diagnosis of the patients that wen trough ankle after resection of a primary malignant tumor of the distal tibia
Time frame: 1 month
osteosarcoma: 5 patientas (2 females of 18 and 15 years old and 3 males of 19, 24 and 16 years old) telangiectasic osteosarcoma (1 female of 21 years old) Ewing sarcoma (1 male of 33 years old)
3 secondary outcomes
mobility
Time frame: 5 month to 10 years follow up
mortality
Time frame: 5 months to 10 years follow up
MSTS SCORE
Time frame: 5 month to 10 years follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background: PubMed 1141281Burrows HJ, Wilson JN, Scales JT. Excision of tumours of humerus and femur, with restoration by internal prostheses. J Bone Joint Surg Br. 1975 May;57(2):148-59.
- Background: PubMed 17715726Ebeid W, Amin S, Abdelmegid A, Refaat Y, Ghoneimy A. Reconstruction of distal tibial defects following resection of malignant tumours by pedicled vascularised fibular grafts. Acta Orthop Belg. 2007 Jun;73(3):354-9.
- Background: PubMed 22863837Liu T, Guo X, Zhang X, Li Z, Zhang Q. Reconstruction with pasteurized autograft for primary malignant bone tumor of distal tibia. Bull Cancer. 2012 Sep;99(9):87-91. doi: 10.1684/bdc.2012.1626.
- Background: PubMed 24751209Ruggieri P, Angelini A, Jorge FD, Maraldi M, Giannini S. Review of foot tumors seen in a university tumor institute. J Foot Ankle Surg. 2014 May-Jun;53(3):282-5. doi: 10.1053/j.jfas.2014.01.015.
- Background: PubMed 23333280Azevedo CP, Casanova JM, Guerra MG, Santos AL, Portela MI, Tavares PF. Tumors of the foot and ankle: a single-institution experience. J Foot Ankle Surg. 2013 Mar-Apr;52(2):147-52. doi: 10.1053/j.jfas.2012.12.004. Epub 2013 Jan 16.
- Background: PubMed 15134614Zeytoonjian T, Mankin HJ, Gebhardt MC, Hornicek FJ. Distal lower extremity sarcomas: frequency of occurrence and patient survival rate. Foot Ankle Int. 2004 May;25(5):325-30. doi: 10.1177/107110070402500509.
- Background: PubMed 23028240Clayer M, Doyle S, Sangha N, Grimer R. The toronto extremity salvage score in unoperated controls: an age, gender, and country comparison. Sarcoma. 2012;2012:717213. doi: 10.1155/2012/717213. Epub 2012 Sep 13.
- Background: PubMed 15864699Ozger H, Eralp L, Turker M, Basaran M. Surgical treatment of malignant tumors of the foot and ankle. Int J Clin Oncol. 2005 Apr;10(2):127-32. doi: 10.1007/s10147-004-0470-9.
- Background: PubMed 8425352Enneking WF, Dunham W, Gebhardt MC, Malawar M, Pritchard DJ. A system for the functional evaluation of reconstructive procedures after surgical treatment of tumors of the musculoskeletal system. Clin Orthop Relat Res. 1993 Jan;(286):241-6.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
patricia bonilla, MD principal investigator
Hospital del Niño
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 Bone Neoplasm, run by Patricia Bonilla at 1 site in Panama.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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 Panama. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact patricia bonilla, MD (+507-5129813 ext. 150, patibh_8@hotmail.com, patriciabonillah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
principal diagnosis of the patients that wen trough ankle after resection of a primary malignant tumor of the distal tibia (time frame: 1 month). 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 NCT03129672, which also lists 9 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 21 Feb 2019.