- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622346
Periprosthetic Fracture Following Tibial Echinococcosis
Periprosthetic Pathologic Fracture Following Tibial Echinococcosis: A Case Report
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Patients with echinococcus infection
- Patients which this infection compromises knee stability.
Exclusion criteria
- bacterial infection
- immunocompromised patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Germano P Nascimento, MD, Centro Hospitalar do Médio Tejo, EPE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Echinococus treatment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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