Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

February 20, 2019 updated by: Patricia Bonilla
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobility
Time Frame: 5 month to 10 years follow up
surgical site infection, non union, malunion, osteosynthesis material failure
5 month to 10 years follow up
mortality
Time Frame: 5 months to 10 years follow up
secundary of the primary tumor diagnosis or metastatic disease of it
5 months to 10 years follow up
MSTS SCORE
Time Frame: 5 month to 10 years follow up
total points score of the msts score at the final follow up
5 month to 10 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patricia Bonilla

Collaborators

Hospital del Niño "Dr. José Renán Esquivel"

Investigators

  • Principal Investigator: patricia bonilla, MD, Hospital del Nino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2014

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

August 31, 2019

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000001 (Kaiser Permanente Southern California IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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