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Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty (CORIHA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: November 6, 2009
Last updated: October 28, 2014
Last verified: October 2014
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.

Condition Intervention
Hip Joint Replacement
Procedure: Cementless one-stage surgical revision

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • re-infection [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Revision for other cause than infection [ Time Frame: 2 years ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Surgical revision
Surgical cementless One-stage revision of the chronic infected hip arthroplasty
Procedure: Cementless one-stage surgical revision
A Cementless one-stage surgical revision is to be performed for all included in the cohort.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01015365

Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital
Aalborg, Denmark, 9000
Orthopaedic department, Aarhus Universityhospital
Aarhus, Denmark, 8000
Gentofte Hospital
Hellerup, Denmark, 2900
Orthopaedic department, Hvidovre Hospital
Hvidovre, Denmark, 2650
Regionalhospital Silkeborg
Silkeborg, Denmark, 8600
Sønderborg Hospital
Sønderborg, Denmark, 6400
Vejle Hospital
Vejle, Denmark, 7100
Regional Hospital Viborg
Viborg, Denmark, 8800
Sponsors and Collaborators
University of Aarhus
Study Chair: Kjeld Soballe, Prof. D.Msc. Lundbeckfoundation center for fast-track hip and knee surgery
Principal Investigator: Jeppe Lange, M.D. Lundbeckfoundation center for fast-track hip and knee surgery
  More Information

Additional Information:
Responsible Party: University of Aarhus Identifier: NCT01015365     History of Changes
Other Study ID Numbers: CORIHA
Study First Received: November 6, 2009
Last Updated: October 28, 2014

Keywords provided by University of Aarhus:
Chronic infected hip arthroplasty
One-stage cementless revision processed this record on May 25, 2017