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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01015365
First received: November 6, 2009
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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
Infection
Hip Joint Replacement
Procedure: Cementless one-stage surgical revision

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Revision for other cause than infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015365

Locations
Denmark
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
Investigators
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:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01015365     History of Changes
Other Study ID Numbers: CORIHA
Study First Received: November 6, 2009
Last Updated: October 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Chronic infected hip arthroplasty
Fast-track
One-stage cementless revision

ClinicalTrials.gov processed this record on November 25, 2014