ClinicalTrials.gov
ClinicalTrials.gov Menu

Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03129672
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Hospital del Niño "Dr. José Renán Esquivel"
Information provided by (Responsible Party):
Patricia Bonilla, Hospital del Niño "Dr. José Renán Esquivel"

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
Bone Neoplasm 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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle
Estimated Study Start Date : May 20, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. mobility [ Time Frame: 5 month to 10 years follow up ]
    surgical site infection, non union, malunion, osteosynthesis material failure

  2. mortality [ Time Frame: 5 months to 10 years follow up ]
    secundary of the primary tumor diagnosis or metastatic disease of it

  3. MSTS SCORE [ Time Frame: 5 month to 10 years follow up ]
    total points score of the msts score at the final follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129672


Contacts
Contact: patricia bonilla, MD +507-5129813 ext 150 patibh_8@hotmail.com, patriciabonillah@gmail.com
Contact: Jorge Navia, MD +57-3155643400 jorgenaviagiraldo@gmail.com, oncologiaortopedica@emcali.net.co

Locations
Panama
Panama Children Hospital Recruiting
Panama, Panama, 0823
Contact: patricia bonilla, MD    +507-5129813 ext 150    patibh_8@hotmail.com   
Contact: Jorge Navia, MD    +57-3155643400    jorgenaviagiraldo@gmail.com   
Sponsors and Collaborators
Patricia Bonilla
Hospital del Niño "Dr. José Renán Esquivel"
Investigators
Principal Investigator: patricia bonilla, MD Hospital del Niño

Publications:

Responsible Party: Patricia Bonilla, Orthopedic Oncologist MD, Hospital del Niño "Dr. José Renán Esquivel"
ClinicalTrials.gov Identifier: NCT03129672     History of Changes
Other Study ID Numbers: 000001
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Patricia Bonilla, Hospital del Niño "Dr. José Renán Esquivel":
allograft
distal tibia sarcoma

Additional relevant MeSH terms:
Sarcoma
Bone Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases