Septic Arthritis of the Native HipNCT04742127
Failure of a Single Surgical Debridement in Septic Arthritis of the Native Hip
An observational study of Septic Arthritis of the Native Hip and Failure of Initial Debridement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Septic arthritis of the native hip poses significant diagnostic and therapeutic challenges as it is considered an orthopedic emergency requiring urgent surgery. Inadequate or delayed treatment is disastrous, resulting in irreversible destruction of the joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Arthritis of the Native Hip, Failure of Initial Debridement
- What is being tested?
- Single surgical debridement
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2021to Dec 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with septic arthritis of the native hip treated at UZ Leuven in the last decade
Who may be able to join
- All microbiology reports for cases of septic arthritis of the native hip joint concerning synovial fluid or solid tissue cultures obtained from arthrocentesis/debridement of the hip, collected from January 1st 2010 to January 1st 2020
- Patients are at least 18 years of age
- Cases with positive cultures in patients of which the initial diagnosis, treatment and follow-up was conducted at UZ Leuven Gasthuisberg
Who cannot join
- History of arthroplasty of the hip in the affected joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Failure of a Single Surgical Debridement in Septic Arthritis of the Native Hip: a Retrospective Study
Septic arthritis of the native hip poses significant diagnostic and therapeutic challenges as it is considered an orthopedic emergency requiring urgent surgery. Inadequate or delayed treatment is disastrous, resulting in irreversible destruction of the joint. Initial treatment usually comprises of arthroscopic or open debridement. According to literature 25-38% of first debridement fail, requiring a second or third intervention or even a staged procedure with femoral head resection and a temporary antibiotic-loaded cement spacer.
Understanding who will succeed and who will fail after a single surgical debridement of a septic hip joint could improve shared decision-making and could help decide which patient would benefit from resection arthroplasty straight away.
In order to gain more insight in clinical factors associated with failure of a single surgical debridement in septic arthritis of the native hip, a retrospective cohort study will be conducted. There are no detailed guidelines for the treatment of septic arthritis of the native hip. Therefore, treatment today is similar to treatment 10 years ago (i.e. the treating surgeon does what he thinks is best for the patient). This lack of a structured approach is the reason for this retrospective study and we aim to come up with principles to guide treatment of future patients.
Read the detailed description
Septic arthritis of the native hip poses significant diagnostic and therapeutic challenges as it is considered an orthopedic emergency requiring urgent surgery. Early diagnosis remains difficult as the golden standard is based on microbiological confirmation of bacteria in synovial fluid or solid tissue biopsies, which can take up to a minimum of 3-5 days or longer. Inadequate or delayed treatment is disastrous, resulting in irreversible destruction of the joint. Initial treatment usually comprises of arthroscopic or open debridement. In comparison to septic arthritis of the knee, patients are more often less fit and the joint is less accessible for arthroscopic intervention. Initial surgical debridement should be performed within 24 hours of occurrence. According to literature 25-38% of first debridement fail, requiring a second or third intervention or even a staged procedure with femoral head resection and a temporary antibiotic-loaded cement spacer.
Understanding who will succeed and who will fail after a single surgical debridement of a septic hip joint could improve shared decision-making and could help decide which patient would benefit from resection arthroplasty straight away. Factors such as a history of inflammatory arthritis, diabetes, a synovial-fluid nucleated cell count of > 85.0 x 10^9 cells/L, S. aureus, delay to surgery and positive cultures of drain fluid were associated with failure of initial debridement, but have not been validated. Considering the increased use of MRI and nuclear imaging in the work-up of these patients, there might be additional useful risk factors, such as extra-articular manifestation of the infection, AVN of the femoral head, severe degeneration of the joint, multi-joint involvement, SUV-max values on FDG-PET-CT and so on.
Most literature surrounding this subject is limited to case reports and case series with small sample sizes. Due to the sizable amounts of tertiary references, a large population of transplant patients treated at the institution UZ Leuven Gasthuisberg, and the own experience of the investigators, the investigators are convinced that the population size at is substantially larger.
In order to gain more insight in clinical factors associated with failure of a single surgical debridement in septic arthritis of the native hip, a retrospective cohort study will be conducted. There are no detailed guidelines for the treatment of septic arthritis of the native hip. Therefore, treatment today is similar to treatment 10 years ago (i.e. the treating surgeon does what he thinks is best for the patient). This lack of a structured approach is the reason for this retrospective study and we aim to come up with principles to guide treatment of future patients.
- Being tested
- Single surgical debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single surgical debridementDiagnostic test
To describe the clinical factors associated with failure of a single surgical debridement in patients with septic arthritis of the native hip.
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic arthritis of the native hip | Not described Receives: Diagnostic Test: Single surgical debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical factors associated with failure of a single surgical debridement
A retrospective data registry containing clinical data of patients with septic arthritis of the native hip will be constructed. This data registry will contain a sizable amount of clinico-pathological features collected from the electronic patient registry. Subsequently, a retrospective cohort study will be conducted in order to establish associations between certain clinical factors and the likelihood of failure of the initial surgical debridement.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Population of patients who would benefit from a staged procedure
A proportion analysis will be conducted in order to find typical characteristics present in patients with septic arthritis of the native hip. These characteristics will be used to find and describe a subpopulation of patients who would benefit from a staged procedure with femoral head resection and a temporary antibiotic-loaded cement spacer followed by total hip arthroplasty straight away, instead of initial debridement of the native hip.
Measured: Through study completion, an average of 1 year
Prevalence of failure of initial debridement
The prevalence of failure of initial debridement will be described using the retrospective dataset.
Measured: Through study completion, an average of 1 year
Prevalence of staged procedure
The prevalence of patients needing a staged procedure will be described using the retrospective dataset.
Measured: Through study completion, an average of 1 year
Mortality
The mortality rate after treatment will be described using the retrospective dataset.
Measured: Through study completion, an average of 1 year
Recurrence
The recurrence rate after treatment will be described using the retrospective dataset.
Measured: Through study completion, an average of 1 year
Risk factors for failure of a single surgical debridement
Risk factors for failure of a single surgical debridement will be identified using the predictive model developed by Hunter et al. This predictive model is a prognostic probability algorithm to predict failure of a single surgical debridement.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start26 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic Arthritis of the Native HipStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742127
- Sponsor's protocol ID
- S64930
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure of a Single Surgical Debridement in Septic Arthritis of the Native Hip: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04742127
- Acronym / sponsor ID
- S64930
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Feb 2021 (actual)
- 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.
Septic arthritis of the native hip poses significant diagnostic and therapeutic challenges as it is considered an orthopedic emergency requiring urgent surgery. Inadequate or delayed treatment is disastrous, resulting in irreversible destruction of the joint. Initial treatment usually comprises of arthroscopic or open debridement. According to literature 25-38% of first debridement fail, requiring a second or third intervention or even a staged procedure with femoral head resection and a temporary antibiotic-loaded cement spacer.
Understanding who will succeed and who will fail after a single surgical debridement of a septic hip joint could improve shared decision-making and could help decide which patient would benefit from resection arthroplasty straight away.
In order to gain more insight in clinical factors associated with failure of a single surgical debridement in septic arthritis of the native hip, a retrospective cohort study will be conducted. There are no detailed guidelines for the treatment of septic arthritis of the native hip. Therefore, treatment today is similar to treatment 10 years ago (i.e. the treating surgeon does what he thinks is best for the patient). This lack of a structured approach is the reason for this retrospective study and we aim to come up with principles to guide treatment of future patients.
Detailed description
Septic arthritis of the native hip poses significant diagnostic and therapeutic challenges as it is considered an orthopedic emergency requiring urgent surgery. Early diagnosis remains difficult as the golden standard is based on microbiological confirmation of bacteria in synovial fluid or solid tissue biopsies, which can take up to a minimum of 3-5 days or longer. Inadequate or delayed treatment is disastrous, resulting in irreversible destruction of the joint. Initial treatment usually comprises of arthroscopic or open debridement. In comparison to septic arthritis of the knee, patients are more often less fit and the joint is less accessible for arthroscopic intervention. Initial surgical debridement should be performed within 24 hours of occurrence. According to literature 25-38% of first debridement fail, requiring a second or third intervention or even a staged procedure with femoral head resection and a temporary antibiotic-loaded cement spacer.
Understanding who will succeed and who will fail after a single surgical debridement of a septic hip joint could improve shared decision-making and could help decide which patient would benefit from resection arthroplasty straight away. Factors such as a history of inflammatory arthritis, diabetes, a synovial-fluid nucleated cell count of > 85.0 x 10^9 cells/L, S. aureus, delay to surgery and positive cultures of drain fluid were associated with failure of initial debridement, but have not been validated. Considering the increased use of MRI and nuclear imaging in the work-up of these patients, there might be additional useful risk factors, such as extra-articular manifestation of the infection, AVN of the femoral head, severe degeneration of the joint, multi-joint involvement, SUV-max values on FDG-PET-CT and so on.
Most literature surrounding this subject is limited to case reports and case series with small sample sizes. Due to the sizable amounts of tertiary references, a large population of transplant patients treated at the institution UZ Leuven Gasthuisberg, and the own experience of the investigators, the investigators are convinced that the population size at is substantially larger.
In order to gain more insight in clinical factors associated with failure of a single surgical debridement in septic arthritis of the native hip, a retrospective cohort study will be conducted. There are no detailed guidelines for the treatment of septic arthritis of the native hip. Therefore, treatment today is similar to treatment 10 years ago (i.e. the treating surgeon does what he thinks is best for the patient). This lack of a structured approach is the reason for this retrospective study and we aim to come up with principles to guide treatment of future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septic arthritis of the native hip | – | Diagnostic Test: Single surgical debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with septic arthritis of the native hip treated at UZ Leuven in the last decade
Key inclusion criteria (3 listed)
- All microbiology reports for cases of septic arthritis of the native hip joint concerning synovial fluid or solid tissue cultures obtained from arthrocentesis/debridement of the hip, collected from January 1st 2010 to January 1st 2020
- Patients are at least 18 years of age
- Cases with positive cultures in patients of which the initial diagnosis, treatment and follow-up was conducted at UZ Leuven Gasthuisberg
Key exclusion criteria (1 listed)
- History of arthroplasty of the hip in the affected joint
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 |
|---|---|---|
| Single surgical debridementTo describe the clinical factors associated with failure of a single surgical debridement in patients with septic arthritis of the native hip. | Diagnostic test | Patients with septic arthritis of the native hip |
Primary outcome
Clinical factors associated with failure of a single surgical debridement
Time frame: Through study completion, an average of 1 year
A retrospective data registry containing clinical data of patients with septic arthritis of the native hip will be constructed. This data registry will contain a sizable amount of clinico-pathological features collected from the electronic patient registry. Subsequently, a retrospective cohort study will be conducted in order to establish associations between certain clinical factors and the likelihood of failure of the initial surgical debridement.
6 secondary outcomes
Population of patients who would benefit from a staged procedure
Time frame: Through study completion, an average of 1 year
Prevalence of failure of initial debridement
Time frame: Through study completion, an average of 1 year
Prevalence of staged procedure
Time frame: Through study completion, an average of 1 year
Mortality
Time frame: Through study completion, an average of 1 year
Recurrence
Time frame: Through study completion, an average of 1 year
Risk factors for failure of a single surgical debridement
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Septic Arthritis of the Native Hip and Failure of Initial Debridement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Clinical factors associated with failure of a single surgical debridement (time frame: Through study completion, an average of 1 year). 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 3 Jul 2024.