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

This study is currently recruiting participants.

Verified March 2012 by University of Aarhus

Sponsor:

Information provided by (Responsible Party):

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01015365

First received: November 6, 2009

Last updated: March 20, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 6, 2009

Last Updated Date

March 20, 2012

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

re-infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01015365 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infection
Hip Replacement Arthroplasty

Intervention ^ICMJE

Procedure: Cementless one-stage surgical revision

A Cementless one-stage surgical revision is to be performed for all included in the cohort.

Study Arm (s)

Surgical revision

Surgical cementless One-stage revision of the chronic infected hip arthroplasty

Intervention: Procedure: Cementless one-stage surgical revision

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

April 2014

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jeppe Lange, M.D.	+45 89 49 96 99	jeppe.lange@ki.au.dk
Contact: Kjeld Soballe, Prof. D.Msc.	+45 89 49 74 29	kjeld@soballe.com

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01015365

Other Study ID Numbers ^ICMJE

CORIHA

Has Data Monitoring Committee

Yes

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

University of Aarhus

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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