InfectionCORIHANCT01015365
Cementless One-stage Revision of the Chronic Infected Hip Arthroplasty
A study testing Cementless one-stage surgical revision in people with Infection and Hip Joint Replacement, run by University of Aarhus at 8 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Hip Joint Replacement
- What is being tested?
- Cementless one-stage surgical revision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 8 sitesDenmark
- Study dates
- Nov 2009to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy under 2 years
- Cognitive dysfunction
- Pre-operative unwillingness to receive blood
- Intravenous drug abuse
- Alcoholism
- Immunocompromised patients
Show all 15Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Orthopaedic Center, Alborg sygehus, Aarhus Universityhospital
Aalborg, 9000
Orthopaedic department, Aarhus Universityhospital
Aarhus, 8000
Gentofte Hospital
Hellerup, 2900
Orthopaedic department, Hvidovre Hospital
Hvidovre, 2650
Regionalhospital Silkeborg
Silkeborg, 8600
Sønderborg Hospital
Sønderborg, 6400
Vejle Hospital
Vejle, 7100
Regional Hospital Viborg
Viborg, 8800
About this study
Official title: 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.
- Conditions
- Infection, Hip Joint Replacement
- Being tested
- Cementless one-stage surgical revision
- Keywords
- Chronic infected hip arthroplasty, Fast-track, One-stage cementless revision
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless one-stage surgical revisionProcedure or surgery
A Cementless one-stage surgical revision is to be performed for all included in the cohort.
| Study group | Role | What they receive |
|---|---|---|
| Surgical revision | Other | Surgical cementless One-stage revision of the chronic infected hip arthroplasty Receives: Procedure: Cementless one-stage surgical revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-infection
Measured: 2 years
Secondary outcomes (1)
Revision for other cause than infection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, Prof. D.Msc., Study chair, Lundbeckfoundation center for fast-track hip and knee surgeryJeppe Lange, M.D., Principal investigator, Lundbeckfoundation center for fast-track hip and knee surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015365
- Sponsor's protocol ID
- CORIHA
- Acronym
- CORIHA
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2009
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cementless One-stage Revision in Fast-track Setting of the Chronic Infected Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01015365
- Acronym / sponsor ID
- CORIHA / CORIHA
- Conditions
- Infection, Hip Joint Replacement
- Keywords
- Chronic infected hip arthroplasty, Fast-track, One-stage cementless revision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical revision | Other | Procedure: Cementless one-stage surgical revisionSurgical cementless One-stage revision of the chronic infected hip arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- Life expectancy under 2 years
- Cognitive dysfunction
- Pre-operative unwillingness to receive blood
- Intravenous drug abuse
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cementless one-stage surgical revisionA Cementless one-stage surgical revision is to be performed for all included in the cohort. | Procedure or surgery | Surgical revision |
Primary outcome
re-infection
Time frame: 2 years
1 secondary outcome
Revision for other cause than infection
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Soballe, Prof. D.Msc. study chair
Lundbeckfoundation center for fast-track hip and knee surgery
Jeppe Lange, M.D. principal investigator
Lundbeckfoundation center for fast-track hip and knee surgery
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cementless one-stage surgical revision in people with Infection and Hip Joint Replacement, run by University of Aarhus at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-infection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.