Distal Tibia Sarcoma Treatment Using Allograft Arthrodesis of the Ankle

• Conditions: Bone Neoplasm

• Registration Number: NCT03129672
• Lead Sponsor: Patricia Bonilla

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)

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 Timeline

• Study Start: 2014-05-20
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-26
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21
• Primary Completion: 2019-06-01
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Panama Children Hospital; 🇵🇦 Panama, Panama