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Periprosthetic Fracture Following Tibial Echinococcosis

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ClinicalTrials.gov Identifier: NCT03622346
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Germano Pereira Nascimento, Centro Hospitalar do Medio Tejo

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 arthroplasty
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Periprosthetic Pathologic Fracture Following Tibial Echinococcosis: A Case Report
Actual Study Start Date : January 5, 2010
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures


Intervention Details:
  • Procedure: Semi-constrained total knee arthroplasty
    Semi-constrained total knee arthroplasty


Primary Outcome Measures :
  1. Pain assessed by numerical rating scale (NRS) [ Time Frame: 6 years ]
    measured with numerical rating scale (NRS), ranging from 0 to 10 (minimum to maximum pain)



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

Inclusion criteria

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

Exclusion criteria

  • bacterial infection
  • immunocompromised patients

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): NCT03622346


Sponsors and Collaborators
Centro Hospitalar do Medio Tejo
Investigators
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Principal Investigator: Germano P Nascimento, MD Centro Hospitalar do Médio Tejo, EPE
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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: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No personal patient information is to be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Germano Pereira Nascimento, Centro Hospitalar do Medio Tejo:
Echinococcosis, Hydatidosis, TKR, Fracture
Additional relevant MeSH terms:
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Echinococcosis
Cestode Infections
Helminthiasis
Parasitic Diseases