Direct Infection of Hip- and Knee ArthroplastyDAIRNCT02087020
Debridement, Antibiotics and Implant Retention in Early Periprosthetic Joint Infection: A Retrospective Cohort Study
An observational study of Direct Infection of Hip- and Knee Arthroplasty, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is recommended in early infections (< 4 weeks) and stable implants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Direct Infection of Hip- and Knee Arthroplasty
- What is being tested?
- Debridement, antibiotics and implant retention
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jun 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Danderyd Hospital is a university hospital affiliated with the Karolinska Institute and is one of the four emergency hospitals in Stockholm, with a catchment area of approximately 500.000 inhabitants. The index cohort was extracted from the local in-hospital surgery database at the Department of Orthopaedic Surgery using ICD 10 coding and surgical intervention coding for PJI treatment.
Who may be able to join
- Patients treated with DAIR for early postoperative periprosthetic joint infection after knee- or hip arthroplasty surgery (<4-6 weeks postoperatively) at our institution between 2007-01-01 and 2012-12-01.
Who cannot join
- Chronic or late presenting periprosthetic joint infection (>6 weeks postoperatively), acute hematogenous periprosthetic joint infection, when the periprosthetic joint infection diagnosis criteria according to American Musculoskeletal Infection Society (MSIS) 2011 definition of PJI definitions were not fulfilled and when the initial surgical treatment was with other treatment protocol than DAIR including one-stage revision and two -stage revision
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success rate of DAIR in early infections and to identify predictors for success. Material and methods: In a retrospective cohort study we included patients with hip- or knee arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic regression analysis was used to identify risk factors affecting success rate. Primary outcome variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors for treatment failure.
- Being tested
- Debridement, antibiotics and implant retention
- Keywords
- Joint Prosthesis, Prosthesis-Related Infections, Joint Diseases, Therapeutic Irrigation, Prostheses and Implants, Arthroplasty Replacement
- Medical subject headings
- Prosthesis-Related Infections, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement, antibiotics and implant retentionProcedure or surgery
DAIR treatment protocol embodies an extensive surgical debridement and a radical excision of infected tissue. This is followed by exchange of modular components (articulating surfaces of the implant such as the femoral head, acetabular liner in total hip arthroplasty and the tibial insert, the polyethylene meniscus, in total knee arthroplasty). The wound is then copiously irrigated (> 9 litre) with 0.9 % sodium chloride and then closed.
| Study group | Role | What they receive |
|---|---|---|
| Periprosthetic joint infection | Patient treated with 'Debridement, antibiotics and implant retention' for early postoperative periprosthetic joint infection at Danderyd Hospital between 2007-01-01 and 2012-12-01 Receives: Procedure: Debridement, antibiotics and implant retention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment
The success rate, in terms of infection eradication without additional surgical methods, of debridement, antibiotics and implant retention in early postoperative periprosthetic joint infection..
Measured: 6 year
Secondary outcomes (1)
Risk factors for treatment failure
Analyze of potential risk factors for treatment failure, age, gender, comorbidities i.e type 1 or 2 diabetes mellitus, renal insufficiency, dementia, systemic inflammatory disease, local or systemic infection, American Society of Anesthesiologists classification, virulence of infecting microbial, hospital stay, typ of arthroplasty, revision arthroplasty, and administration of antibiotics prior to debridement, antibiotics and implant retention treatment.
Measured: 6 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Direct Infection of Hip- and Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Olof G Skoldenberg, MD,PhD, Principal investigator, Orthopaedic department, Danderyds hospitalSebastian S Mukka, MD, Study chair, Orthopaedic department, Danderyds hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087020
- Sponsor's protocol ID
- DAIR-3
- Acronym
- DAIR
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
PubMed 15483283Bergkvist M, Mukka SS, Johansson L, Ahl TE, Sayed-Noor AS, Skoldenberg OG, Eisler T. Debridement, antibiotics and implant retention in early periprosthetic joint infection. Hip Int. 2016 Mar-Apr;26(2):138-43. doi: 10.5301/hipint.5000328. Epub 2016 Feb 8.
PubMed 26868114
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debridement, Antibiotics and Implant Retention in Early Periprosthetic Joint Infection: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT02087020
- Acronym / sponsor ID
- DAIR / DAIR-3
- Keywords
- Joint Prosthesis, Prosthesis-Related Infections, Joint Diseases, Therapeutic Irrigation, Prostheses and Implants, Arthroplasty Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Mar 2014 (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.
Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success rate of DAIR in early infections and to identify predictors for success. Material and methods: In a retrospective cohort study we included patients with hip- or knee arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic regression analysis was used to identify risk factors affecting success rate. Primary outcome variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors for treatment failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periprosthetic joint infection | – | Procedure: Debridement, antibiotics and implant retentionPatient treated with 'Debridement, antibiotics and implant retention' for early postoperative periprosthetic joint infection at Danderyd Hospital between 2007-01-01 and 2012-12-01 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Danderyd Hospital is a university hospital affiliated with the Karolinska Institute and is one of the four emergency hospitals in Stockholm, with a catchment area of approximately 500.000 inhabitants. The index cohort was extracted from the local in-hospital surgery database at the Department of Orthopaedic Surgery using ICD 10 coding and surgical intervention coding for PJI treatment.
Key inclusion criteria (1 listed)
- Patients treated with DAIR for early postoperative periprosthetic joint infection after knee- or hip arthroplasty surgery (<4-6 weeks postoperatively) at our institution between 2007-01-01 and 2012-12-01.
Key exclusion criteria (1 listed)
- Chronic or late presenting periprosthetic joint infection (>6 weeks postoperatively), acute hematogenous periprosthetic joint infection, when the periprosthetic joint infection diagnosis criteria according to American Musculoskeletal Infection Society (MSIS) 2011 definition of PJI definitions were not fulfilled and when the initial surgical treatment was with other treatment protocol than DAIR including one-stage revision and two -stage revision
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 |
|---|---|---|
| Debridement, antibiotics and implant retentionDAIR treatment protocol embodies an extensive surgical debridement and a radical excision of infected tissue. This is followed by exchange of modular components (articulating surfaces of the implant such as the femoral head, acetabular liner in total hip arthroplasty and the tibial insert, the polyethylene meniscus, in total knee arthroplasty). The wound is then copiously irrigated (> 9 litre) with 0.9 % sodium chloride and then closed. | Procedure or surgery | Periprosthetic joint infection |
Primary outcome
Successful treatment
Time frame: 6 year
The success rate, in terms of infection eradication without additional surgical methods, of debridement, antibiotics and implant retention in early postoperative periprosthetic joint infection..
1 secondary outcome
Risk factors for treatment failure
Time frame: 6 year
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 14 Mar 2014.
- Background: PubMed 15483283Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.
- Derived from this study: PubMed 26868114Bergkvist M, Mukka SS, Johansson L, Ahl TE, Sayed-Noor AS, Skoldenberg OG, Eisler T. Debridement, antibiotics and implant retention in early periprosthetic joint infection. Hip Int. 2016 Mar-Apr;26(2):138-43. doi: 10.5301/hipint.5000328. Epub 2016 Feb 8.
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.
Olof G Skoldenberg, MD,PhD principal investigator
Orthopaedic department, Danderyds hospital
Sebastian S Mukka, MD study chair
Orthopaedic department, Danderyds hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Direct Infection of Hip- and Knee Arthroplasty, run by Danderyd Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Successful treatment (time frame: 6 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087020, which also lists 2 linked publications.
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 14 Mar 2014.