Periprosthetic Fracture Following Tibial Echinococcosis

Sponsor

Centro Hospitalar do Medio Tejo (Other)

Overall Status

Completed

CT.gov ID

NCT03622346

Collaborator

(none)

Enrollment

89.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Cystic Echinococcus in the bone is rare, comprising 0.5% to 2.5% of all human hydatidosis Association of Hydatid disease to pathologic fractures involving knee prosthesis have not yet been described A combined surgical and medical approach is of paramount importance to avoid recurrence Resulting osseus defects is challenging and require specific prosthesis when treating this entity.

Condition or Disease	Intervention/Treatment	Phase
Cystic Echinococcus	Procedure: Semi-constrained total knee arthroplasty	N/A

Detailed Description

Hydatid disease in humans caused by the parasitic tapeworm Echinococcus granulosus has an osseous involvement of about 0.5% to 2.5% of all cases in humans. The location of hydatid cysts in the tibia is seldom described in the medical literature, and its diagnosis and treatment is challenging.

This paper presents a patient, with a long term, well tolerated, bilateral total knee arthroplasty (TKA), treated at our clinic, with a recent history of pain and oedema in her left upper leg. After achieving a, radiologically and histopathologically, well documented, diagnosis of Echinococcosis lesion in her left proximal tibia, a surgical intervention was planed, a wide resection of the cyst performed, and a specific anti-helmintic therapy was instituted. Four years later the patient returns to the investigators observation complaining of pain and unable to bear weight on her left knee, from which a pathologic fracture, adjacent to the tibial component was diagnosed.

After surgical debridement of the newly advanced hydatid cyst growth, the TKA was revised, and due to the tibial component failure and the femoral implant loosening, a semi-constrained total knee revision arthroplasty was executed. Functional outcome was excellent.

Although challenges in treatment of musculoskeletal hydatid cysts (HC) lesions have been documented, data regarding the musculoskeletal HC lesions resembling tumor is scarce, and those resulting in a prosthetic failure haven't been published. The authors intend to add data concerning the therapeutic approach to this entity.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Just one patient, subject to two surgeries: curettage and external fixation; subsequently the patient underwent total knee arthroplastyJust one patient, subject to two surgeries: curettage and external fixation; subsequently the patient underwent total knee arthroplasty

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Periprosthetic Pathologic Fracture Following Tibial Echinococcosis: A Case Report

Actual Study Start Date :

Jan 5, 2010

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2017

Outcome Measures

Primary Outcome Measures

Pain assessed by numerical rating scale (NRS) [6 years]
measured with numerical rating scale (NRS), ranging from 0 to 10 (minimum to maximum pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria

Patients with echinococcus infection
Patients which this infection compromises knee stability.

Exclusion criteria

bacterial infection
immunocompromised patients

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro Hospitalar do Medio Tejo

Investigators

Principal Investigator: Germano P Nascimento, MD, Centro Hospitalar do Médio Tejo, EPE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Germano Pereira Nascimento, Dr. Germano Nascimento, Principal Investigator, Centro Hospitalar do Medio Tejo

ClinicalTrials.gov Identifier:

NCT03622346

Other Study ID Numbers:

Echinococus treatment

First Posted:

Aug 9, 2018

Last Update Posted:

Aug 9, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Germano Pereira Nascimento, Dr. Germano Nascimento, Principal Investigator, Centro Hospitalar do Medio Tejo

Echinococcosis, Hydatidosis, TKR, Fracture

Additional relevant MeSH terms:

Echinococcosis

Study Results

No Results Posted as of Aug 9, 2018