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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01015365

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection Hip Joint Replacement	Procedure: Cementless one-stage surgical revision	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

re-infection [2 years]

Secondary Outcome Measures

Revision for other cause than infection [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital	Aalborg	Denmark	9000
2	Orthopaedic department, Aarhus Universityhospital	Aarhus	Denmark	8000
3	Gentofte Hospital	Hellerup	Denmark	2900
4	Orthopaedic department, Hvidovre Hospital	Hvidovre	Denmark	2650
5	Regionalhospital Silkeborg	Silkeborg	Denmark	8600
6	Sønderborg Hospital	Sønderborg	Denmark	6400
7	Vejle Hospital	Vejle	Denmark	7100
8	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Webpage of the Lundbeckfoundation center for fast-track hip and knee surgery

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT01015365

Other Study ID Numbers:

CORIHA

First Posted:

Nov 18, 2009

Last Update Posted:

Nov 20, 2017

Last Verified:

Nov 1, 2017

Keywords provided by University of Aarhus

Chronic infected hip arthroplasty

Fast-track

One-stage cementless revision

Study Results

No Results Posted as of Nov 20, 2017