Cystic EchinococcusNCT03622346
Periprosthetic Fracture Following Tibial Echinococcosis
A study testing Semi-constrained total knee arthroplasty in people with Cystic Echinococcus, run by Centro Hospitalar do Medio Tejo.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cystic Echinococcus
- What is being tested?
- Semi-constrained total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2010to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with echinococcus infection
- Patients which this infection compromises knee stability.
Who cannot join
- bacterial infection
- immunocompromised patients
About this study
Official title: Periprosthetic Pathologic Fracture Following Tibial Echinococcosis: A Case Report
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.
Read the 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.
- Conditions
- Cystic Echinococcus
- Being tested
- Semi-constrained total knee arthroplasty
- Keywords
- Echinococcosis, Hydatidosis, TKR, Fracture
- Medical subject headings
- Echinococcosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-constrained total knee arthroplastyProcedure or surgery
Semi-constrained total knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by numerical rating scale (NRS)
measured with numerical rating scale (NRS), ranging from 0 to 10 (minimum to maximum pain)
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start5 Jan 2010
- Primary completion1 Jul 2016
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic EchinococcusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Just one patient, subject to two surgeries: curettage and external fixation; subsequently the patient underwent total knee arthroplasty
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Medio Tejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Germano Pereira Nascimento, Centro Hospitalar do Medio Tejo
- Investigators
- Germano P Nascimento, MD, Principal investigator, Centro Hospitalar do Médio Tejo, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622346
- Sponsor's protocol ID
- Echinococus treatment
- Status last verified
- Aug 2018
- First submitted
- 19 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal patient information is to be made available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Pathologic Fracture Following Tibial Echinococcosis: A Case Report
- ClinicalTrials.gov ID
- NCT03622346
- Acronym / sponsor ID
- Echinococus treatment
- Conditions
- Cystic Echinococcus
- Keywords
- Echinococcosis, Hydatidosis, TKR, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centro Hospitalar do Medio TejoUniversity, hospital or other
- Study start
- 5 Jan 2010 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Just one patient, subject to two surgeries: curettage and external fixation; subsequently the patient underwent total knee arthroplasty
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with echinococcus infection
- Patients which this infection compromises knee stability.
Key exclusion criteria (2 listed)
- bacterial infection
- immunocompromised patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-constrained total knee arthroplastySemi-constrained total knee arthroplasty | Procedure or surgery | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No. No personal patient information is to be made available.
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Cystic Echinococcosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Germano P Nascimento, MD principal investigator
Centro Hospitalar do Médio Tejo, EPE
Questions about this trial
What is this clinical trial studying?
A study testing Semi-constrained total knee arthroplasty in people with Cystic Echinococcus, run by Centro Hospitalar do Medio Tejo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by numerical rating scale (NRS) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.