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

November 17, 2017 updated by: University of Aarhus

Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital
      • Aarhus, Denmark, 8000
        • Orthopaedic department, Aarhus Universityhospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Hvidovre, Denmark, 2650
        • Orthopaedic department, Hvidovre Hospital
      • Silkeborg, Denmark, 8600
        • Regionalhospital Silkeborg
      • Sønderborg, Denmark, 6400
        • Sønderborg Hospital
      • Vejle, Denmark, 7100
        • Vejle Hospital
      • Viborg, Denmark, 8800
        • Regional Hospital Viborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
re-infection
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Revision for other cause than infection
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 17, 2009

First Posted (Estimate)

November 18, 2009

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CORIHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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