Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty (CORIHA)
This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01015365
First received: November 6, 2009
Last updated: September 26, 2012
Last verified: September 2012
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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 Replacement Arthroplasty |
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 |
Resource links provided by NLM:
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: | January 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015365
Contacts
| 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 |
Locations
| Denmark | |
| Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital | Recruiting |
| Aalborg, Denmark, 9000 | |
| Orthopaedic department, Aarhus Universityhospital | Recruiting |
| Aarhus, Denmark, 8000 | |
| Gentofte Hospital | Recruiting |
| Hellerup, Denmark, 2900 | |
| Orthopaedic department, Hvidovre Hospital | Recruiting |
| Hvidovre, Denmark, 2650 | |
| Regionalhospital Silkeborg | Recruiting |
| Silkeborg, Denmark, 8600 | |
| Sønderborg Hospital | Recruiting |
| Sønderborg, Denmark, 6400 | |
| Vejle Hospital | Recruiting |
| Vejle, Denmark, 7100 | |
| Regional Hospital Viborg | Recruiting |
| 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: | September 26, 2012 |
| 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 May 21, 2013