Clinical trial NCT03129672: Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
Official title: Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Neoplasm
Keywords: allograft
distal tibia sarcoma
Lead sponsor: Hospital del Niño "Dr. José Renán Esquivel"
Sponsor class: OTHER
Collaborators: name: Hospital del Niño "Dr. José Renán Esquivel"
First posted: 2017-04-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients that were diagnosis with primary malignant bone tumor of the distal tibia and went trough resection and reconstruction with allograft

Brief 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)

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).

Eligibility criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

* none histopatologic proved diagnosis
* patients that received other kind of surgical treatment

Primary outcomes:
measure: principal diagnosis of the patients that wen trough ankle after resection of a primary malignant tumor of the distal tibia
timeFrame: 1 month
Secondary outcomes:
measure: mobility
timeFrame: 5 month to 10 years follow up
measure: mortality
timeFrame: 5 months to 10 years follow up
measure: MSTS SCORE
timeFrame: 5 month to 10 years follow up
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Panama Children Hospital
Study officials:
affiliation: Hospital del Niño
name: patricia bonilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ebeid 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.
citation: Liu 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.
citation: Ruggieri 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.
citation: Azevedo 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.
citation: Zeytoonjian 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.
citation: Clayer 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.
citation: Ozger 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.
citation: Enneking 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.