Does the Type of Ventilation Affect the Risk for Infections After Hip Replacements?
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ClinicalTrials.gov Identifier: NCT05932823 |
Recruitment Status :
Completed
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
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Background: During hip replacement surgery, there is a risk that bacteria in the operating room can cause an infection. To try and reduce this risk, some operating rooms use a special system called laminar airflow (LAF), which reduces the number of bacteria in the air. However, it's not clear if LAF is better than the older system, called turbulent airflow (TAF), for preventing infections.
Aim: The aim of this study is to compare the two airflow systems and see if LAF is better at preventing infections after hip replacement surgery.
Methods: Information from a database containing all hip replacement surgeries done in Denmark between 2010 and 2020 is examined. The number of infections that occur in surgeries done with LAF, which reduces the number of bacteria in the air during surgery, is compared to the number of infections that occur in surgeries done with TAF. To make the results more credible, the data from the hip register was combined with data from the bacterial cultures taken during surgery.
Use and relevance: Infections after hip replacement surgery can be very serious and expensive to treat. Hospitals need to choose the best airflow system to help prevent these infections. This study is important because it gives more accurate information about which system is better at preventing infections and can help hospitals make better choices when they are designing or renovating operating rooms.
Condition or disease | Intervention/treatment |
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Hip Prosthesis Infection | Other: Laminary airflow |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 110000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 12 Months |
Official Title: | Airflow and Hip Prosthesis Infections: A Registry Study Comparing Laminar vs. Turbulent Flow in the Danish Hip Arthroplasty Register. |
Actual Study Start Date : | January 1, 2010 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | December 31, 2021 |
Group/Cohort | Intervention/treatment |
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Laminar Airflow
total hip arthroplasty performed in an operating room using laminar airflow ventilation system
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Other: Laminary airflow
A ventilation system that reduces the number of bacteria in the air compared to conventional ventilation. |
Turbulent Airflow
total hip arthroplasty performed in an operating room using turbulent airflow ventilation system
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- Revisions due to periprosthetic joint infections at 90 days after surgery [ Time Frame: t=90 days ]PJI is defined as revision with 2 or more positive biopsies with the same bacteria in MiBa or revision reported to DHR as PJI at t=90 days.
- Revisions due to periprosthetic joint infections at 365 days after surgery [ Time Frame: t=365 days ]PJI is defined as revision with 2 or more positive biopsies with the same bacteria in MiBa or revision reported to DHR as PJI at t=365 days.
- Revisions due to aseptic loosening at 90 days after surgery [ Time Frame: t=90 days ]Aseptic loosening is defined as aseptic loosening being reported to DHR as reason for revision at t=90 days.
- Revisions due to aseptic loosening at 365 days after surgery [ Time Frame: t=365 days ]Aseptic loosening is defined as aseptic loosening being reported to DHR as reason for revision at t=365 days.
- Any revision at 90 days after surgery [ Time Frame: t=90 days ]Any revision is defined as revision being reported to DHR at t=90 days.
- Any revision at 365 days after surgery [ Time Frame: t=365 days ]Any revision is defined as revision being reported to DHR at t=365 days.
- Sensitivity analysis: Alternative PJI diagnosis at 90 days [ Time Frame: t=90 days ]Primary revision registered as periprosthetic joint infection to DHR or with one or more positive biopsies of a bacterium at at t=90 days.
- Sensitivity analysis: Alternative PJI diagnosis at 365 days [ Time Frame: t=365 days ]Primary revision registered as periprosthetic joint infection to DHR or with one or more positive biopsies of a bacterium at at t=365 days.
- Sensitivity analysis: Viewing of which patients with 1 positive bacterial culture that receive antibiotics at 90 days [ Time Frame: t=90 ]Primary revision registered to DHR with 1 positive biopsy of a bacterium AND the prescription of a relevant antibiotic at t=90 days.
- Sensitivity analysis: Viewing of which patients with 1 positive bacterial culture that receive antibiotics at 365 days [ Time Frame: t=365 ]Primary revision registered to DHR with 1 positive biopsy of a bacterium AND the prescription of a relevant antibiotic at t=365 days.
- PJI in primary surgery between 2017-2020 at 90 days [ Time Frame: t=90 ]Analysis for the primary endpoint, but for data collected between 2017-2020, allowing for adjustment for BMI and ASA as possible confounders, as these variables are only registered in this period
- PJI in primary surgery between 2017-2020 at 365 days [ Time Frame: t=365 ]Analysis for the primary endpoint, but for data collected between 2017-2020, allowing for adjustment for BMI and ASA as possible confounders, as these variables are only registered in this period
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Primary Total hip arthroplasty performed in Denmark between 2010 and 2020
Exclusion Criteria:
- Tumor or metastasis as indication for total hip arthroplasty
Documents provided by Jacob Moflag Svensson, MD, University Hospital Bispebjerg and Frederiksberg:
Publications:
Responsible Party: | Jacob Moflag Svensson, MD, MD, University Hospital Bispebjerg and Frederiksberg |
ClinicalTrials.gov Identifier: | NCT05932823 |
Other Study ID Numbers: |
P-2019-796 |
First Posted: | July 6, 2023 Key Record Dates |
Last Update Posted: | July 6, 2023 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Danish microbiology register periprosthetic joint infection laminar airflow turbulent airflow airflow |
total hip arthroplasty Danish hip arthroplasty register ventilation system total hip replacement hip prosthesis infection |
Infections Communicable Diseases Disease Attributes Pathologic Processes |