Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

Sponsor
Patricia Bonilla (Other)
Overall Status
Unknown status
CT.gov ID
NCT03129672
Collaborator
Hospital del Niño "Dr. José Renán Esquivel" (Other)
20
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Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Procedure: allograft arthrodesis of ankle

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

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
Actual Study Start Date :
May 20, 2014
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Aug 31, 2019

Outcome Measures

Primary Outcome Measures

  1. principal diagnosis of the patients that wen trough ankle after resection of a primary malignant tumor of the distal tibia [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)

Secondary Outcome Measures

  1. mobility [5 month to 10 years follow up]

    surgical site infection, non union, malunion, osteosynthesis material failure

  2. mortality [5 months to 10 years follow up]

    secundary of the primary tumor diagnosis or metastatic disease of it

  3. MSTS SCORE [5 month to 10 years follow up]

    total points score of the msts score at the final follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Panama Children Hospital Panama Panama 0823

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Patricia Bonilla, Orthopedic Oncologist MD, Hospital del Niño "Dr. José Renán Esquivel"
ClinicalTrials.gov Identifier:
NCT03129672
Other Study ID Numbers:
  • 000001
First Posted:
Apr 26, 2017
Last Update Posted:
Feb 21, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Patricia Bonilla, Orthopedic Oncologist MD, Hospital del Niño "Dr. José Renán Esquivel"
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2019