Femoral Neck FractureDAIRNCT02771639
Early Periprosthetic Joint Infection and Outcome Debridement, Antibiotics and Implant Retention
An observational study of Femoral Neck Fracture and Infection, run by Sundsvall Hospital.
Trial summary
Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Neck Fracture, Infection
- What is being tested?
- Hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 736 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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: Patients treated with a hip arthroplasty for a displaced femoral neck fracture at Sundsvall hospital, Sweden between 2006 and 2015. All patients were included.
Who may be able to join
- Displaced femoral neck fracture
- Treated with a primary hip arthroplasty
Who cannot join
None listed.
About this study
Official title: Early Periprosthetic Joint Infection and Debridement, Antibiotics and Implant Retention in Arthroplasty for Femoral Neck Fracture
Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty.
Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.
- Conditions
- Femoral Neck Fracture, Infection
- Being tested
- Hip arthroplasty
- Keywords
- Hip arthroplasty, periprosthetic joint infection, outcome
- Medical subject headings
- Femoral Neck Fractures, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroplastyProcedure or surgery
Treatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture
| Study group | Role | What they receive |
|---|---|---|
| Femoral neck fractures | Patients admitted to Sundsvall hospital for a displaced femoral neck fracture and treated with a hip arthroplasty Receives: Procedure: Hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of periprosthetic joint infection
The incidence of periprosthetic joint infection
Measured: 1 year
Secondary outcomes (1)
The rate of healed periprosthetic joint infections after treatment with surgical debridement.
The rate of healed periprosthetic joint infections after treatment with surgical debridement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FractureStudies 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
- 736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Mukka, M.D, Ph.D, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771639
- Sponsor's protocol ID
- DAIR_SM
- Acronym
- DAIR
- Status last verified
- May 2016
- First submitted
- 8 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No individual data
Publications
Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966.
PubMed 23230301Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.
PubMed 23083433Edwards C, Counsell A, Boulton C, Moran CG. Early infection after hip fracture surgery: risk factors, costs and outcome. J Bone Joint Surg Br. 2008 Jun;90(6):770-7. doi: 10.1302/0301-620X.90B6.20194.
PubMed 18539671Fisman DN, Reilly DT, Karchmer AW, Goldie SJ. Clinical effectiveness and cost-effectiveness of 2 management strategies for infected total hip arthroplasty in the elderly. Clin Infect Dis. 2001 Feb 1;32(3):419-30. doi: 10.1086/318502. Epub 2001 Jan 26.
PubMed 11170950Noailles T, Brulefert K, Chalopin A, Longis PM, Gouin F. What are the risk factors for post-operative infection after hip hemiarthroplasty? Systematic review of literature. Int Orthop. 2016 Sep;40(9):1843-8. doi: 10.1007/s00264-015-3033-y. Epub 2015 Nov 27.
PubMed 26611729
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Periprosthetic Joint Infection and Debridement, Antibiotics and Implant Retention in Arthroplasty for Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT02771639
- Acronym / sponsor ID
- DAIR / DAIR_SM
- Conditions
- Femoral Neck Fracture, Infection
- Keywords
- Hip arthroplasty, periprosthetic joint infection, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 736 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 May 2016 (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 severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty.
Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral neck fractures | – | Procedure: Hip arthroplastyPatients admitted to Sundsvall hospital for a displaced femoral neck fracture and treated with a hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with a hip arthroplasty for a displaced femoral neck fracture at Sundsvall hospital, Sweden between 2006 and 2015. All patients were included.
Key inclusion criteria (2 listed)
- Displaced femoral neck fracture
- Treated with a primary hip arthroplasty
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hip arthroplastyTreatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture | Procedure or surgery | Femoral neck fractures |
Primary outcome
Rate of periprosthetic joint infection
Time frame: 1 year
The incidence of periprosthetic joint infection
1 secondary outcome
The rate of healed periprosthetic joint infections after treatment with surgical debridement.
Time frame: 6 months
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 13 May 2016.
- Background: PubMed 23230301Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966.
- Background: PubMed 23083433Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Karrholm J, Garellick G, Pulkkinen P, Eskelinen A, Makela K, Engesaeter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918.
- Background: PubMed 18539671Edwards C, Counsell A, Boulton C, Moran CG. Early infection after hip fracture surgery: risk factors, costs and outcome. J Bone Joint Surg Br. 2008 Jun;90(6):770-7. doi: 10.1302/0301-620X.90B6.20194.
- Background: PubMed 11170950Fisman DN, Reilly DT, Karchmer AW, Goldie SJ. Clinical effectiveness and cost-effectiveness of 2 management strategies for infected total hip arthroplasty in the elderly. Clin Infect Dis. 2001 Feb 1;32(3):419-30. doi: 10.1086/318502. Epub 2001 Jan 26.
- Background: PubMed 26611729Noailles T, Brulefert K, Chalopin A, Longis PM, Gouin F. What are the risk factors for post-operative infection after hip hemiarthroplasty? Systematic review of literature. Int Orthop. 2016 Sep;40(9):1843-8. doi: 10.1007/s00264-015-3033-y. Epub 2015 Nov 27.
- Individual participant dataSharing planned: Undecided. No individual data
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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.
Sebastian Mukka, M.D, Ph.D principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture and Infection, run by Sundsvall Hospital.
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 0 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of periprosthetic joint infection (time frame: 1 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 NCT02771639, which also lists 5 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 13 May 2016.