Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty

Infection Clinical Trial

— CORIHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015365
• Other study ID #: CORIHA
• Status: Completed
• Phase: N/A
• First received: November 6, 2009
• Last updated: November 17, 2017
• Start date: November 2009
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Joint Replacement
• Infection

Intervention

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

Locations

Country	Name	City	State
Denmark	Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital	Aalborg
Denmark	Orthopaedic department, Aarhus Universityhospital	Aarhus
Denmark	Gentofte Hospital	Hellerup
Denmark	Orthopaedic department, Hvidovre Hospital	Hvidovre
Denmark	Regionalhospital Silkeborg	Silkeborg
Denmark	Sønderborg Hospital	Sønderborg
Denmark	Vejle Hospital	Vejle
Denmark	Regional Hospital Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	re-infection		2 years
Secondary	Revision for other cause than infection		2 years

External Links

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