This trial is active, not recruiting.

Conditions infection, hip joint replacement
Treatment cementless one-stage surgical revision
Sponsor University of Aarhus
Start date November 2009
End date October 2016
Trial size 100 participants
Trial identifier NCT01015365, CORIHA


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

time frame: 2 years

Secondary Outcomes

Revision for other cause than infection
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty
Principal investigator Jeppe Lange, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.