Clinical trial NCT01015365: Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty
Official title: Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Hip Joint Replacement
Keywords: Chronic infected hip arthroplasty
Fast-track
One-stage cementless revision
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesise that cementless one-stage exchange revision surgery can be performed in patients with chronically infected hip replacement with substantial benefits for the patients, in terms of fast rehabilitation, low re-revision rates and good long term results.


Eligibility criteria: Inclusion Criteria:

* Patient with clinical signs of infection for more than 4 weeks, arising from total hip arthroplasty (primary and revision), resurfacing hip arthroplasty or hemi-hip arthroplasty
* Informed oral and written consent given

Exclusion Criteria:

* Life expectancy under 2 years
* 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

Primary outcomes:
measure: re-infection
timeFrame: 2 years
Secondary outcomes:
measure: Revision for other cause than infection
timeFrame: 2 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital
city: Aarhus
country: Denmark
facility: Orthopaedic department, Aarhus Universityhospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Hvidovre
country: Denmark
facility: Orthopaedic department, Hvidovre Hospital
city: Silkeborg
country: Denmark
facility: Regionalhospital Silkeborg
city: Sønderborg
country: Denmark
facility: Sønderborg Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Lundbeckfoundation center for fast-track hip and knee surgery
name: Kjeld Soballe, Prof. D.Msc.
role: STUDY_CHAIR
affiliation: Lundbeckfoundation center for fast-track hip and knee surgery
name: Jeppe Lange, M.D.
role: PRINCIPAL_INVESTIGATOR
References: