Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty
NCT ID: NCT01015365
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2009-11-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgical revision
Surgical cementless One-stage revision of the chronic infected hip arthroplasty
Cementless one-stage surgical revision
A Cementless one-stage surgical revision is to be performed for all included in the cohort.
Interventions
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Cementless one-stage surgical revision
A Cementless one-stage surgical revision is to be performed for all included in the cohort.
Eligibility Criteria
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Inclusion Criteria
* Informed oral and written consent given
Exclusion Criteria
* Cognitive dysfunction
* Pre-operative unwillingness to receive blood
* Intravenous drug abuse
* Alcoholism
* Immunocompromised patients
* Patients receiving immunosuppressive medication
* Ongoing systemic inflammatory disease
* Poorly regulated diabetes mellitus
* Renal failure (requiring dialysis)
* Acute systemic inflammatory response syndrome with proven infection (sepsis)
* Signs of coexisting active long-term local infection (i.e. endocarditis)
* Previous two-stage revision of hip arthroplasty due to ipsilateral chronic infection (regardless of symptom free interval) or contralateral chronic infection (within the last 2 years).
* \< 6 weeks since last surgery of the affected hip
* If definition of infection is not fulfilled: infection defined as Culture positive: ≥ 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) Culture negative: \< 3 positive intraoperative cultures (tissue biopsies a.m. Kamme-Lindberg) + Chronic fistula with history of previous or existing secretion or Positive cultures in pre-operatively joint fluid aspiration with other clinical signs of infection or Visual pus or purulent fluid during exchange procedure with clinical signs of infection
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Kjeld Soballe, Prof. D.Msc.
Role: STUDY_CHAIR
Lundbeckfoundation center for fast-track hip and knee surgery
Jeppe Lange, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lundbeckfoundation center for fast-track hip and knee surgery
Locations
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Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital
Aalborg, , Denmark
Orthopaedic department, Aarhus Universityhospital
Aarhus, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Orthopaedic department, Hvidovre Hospital
Hvidovre, , Denmark
Regionalhospital Silkeborg
Silkeborg, , Denmark
Sønderborg Hospital
Sønderborg, , Denmark
Vejle Hospital
Vejle, , Denmark
Regional Hospital Viborg
Viborg, , Denmark
Countries
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Related Links
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Webpage of the Lundbeckfoundation center for fast-track hip and knee surgery
Other Identifiers
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CORIHA
Identifier Type: -
Identifier Source: org_study_id