Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

Bone Neoplasm Clinical Trial

Official title:

Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129672
• Other study ID #: 000001
• Status: Recruiting
• Start date: May 20, 2014
• Est. completion date: August 31, 2019

Study information

• Verified date: February 2019
• Source: Hospital del Niño "Dr. José Renán Esquivel"
• Contact: patricia bonilla, MD
• Phone: +507-5129813
• Email: patibh_8[@]hotmail.com, patriciabonillah[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasm
• Bone Neoplasms
• Sarcoma

Intervention

Procedure:
• allograft arthrodesis of ankle
patients that underwent trought a block resection of a malignant tumor of the distal tibia and reconstruction with allograft arthrodesis

Locations

Country	Name	City	State
Panama	Panama Children Hospital	Panama

Sponsors (2)

Lead Sponsor	Collaborator
Patricia Bonilla	Hospital del Niño "Dr. José Renán Esquivel"

Country where clinical trial is conducted

Panama, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Ozger H, Eralp L, Türker M, Basaran M. Surgical treatment of malignant tumors of the foot and ankle. Int J Clin Oncol. 2005 Apr;10(2):127-32. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 month
Secondary	mobility	surgical site infection, non union, malunion, osteosynthesis material failure	5 month to 10 years follow up
Secondary	mortality	secundary of the primary tumor diagnosis or metastatic disease of it	5 months to 10 years follow up
Secondary	MSTS SCORE	total points score of the msts score at the final follow up	5 month to 10 years follow up