Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

NCT03129672 | Unknown

• 1 other identifier: 000001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Bone Neoplasm

Keywords

allograft; distal tibia sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• mobility

  5 month to 10 years follow up

• mortality

  5 months to 10 years follow up

• MSTS SCORE

  5 month to 10 years follow up

Interventions

allograft arthrodesis of ankle PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Patricia Bonilla: lead
• Hospital del Niño "Dr. José Renán Esquivel": collaborator

Study Sites (1)

Panama Children Hospital

Panama City, 0823, Panama

RECRUITING

Related Publications (9)

• 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.

  PMID: 1141281 BACKGROUND

• 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.

  PMID: 17715726 BACKGROUND

• 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.

  PMID: 22863837 BACKGROUND

• 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.

  PMID: 24751209 BACKGROUND

• 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.

  PMID: 23333280 BACKGROUND

• 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.

  PMID: 15134614 BACKGROUND

• 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.

  PMID: 23028240 BACKGROUND

• 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.

  PMID: 15864699 BACKGROUND

• 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.

  PMID: 8425352 BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• patricia bonilla, MD

  Hospital del Niño

  PRINCIPAL INVESTIGATOR

Central Study Contacts

patricia bonilla, MD

CONTACT

+507-5129813; patibh_8@hotmail.com, patriciabonillah@gmail.com

Jorge Navia, MD

CONTACT

+57-3155643400; jorgenaviagiraldo@gmail.com, oncologiaortopedica@emcali.net.co

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Oncologist MD

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: April 26, 2017
• Study Start: May 20, 2014
• Primary Completion: June 1, 2019
• Study Completion: August 31, 2019
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

PA (1)