Failure of Initial Debridement Clinical Trial
Official title:
Failure of a Single Surgical Debridement in Septic Arthritis of the Native Hip: a Retrospective Study
| Verified date | January 2021 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - History of arthroplasty of the hip in the affected joint |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | UZ Leuven | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Through study completion, an average of 1 year | |
| Secondary | 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. | Through study completion, an average of 1 year | |
| Secondary | Prevalence of failure of initial debridement | The prevalence of failure of initial debridement will be described using the retrospective dataset. | Through study completion, an average of 1 year | |
| Secondary | Prevalence of staged procedure | The prevalence of patients needing a staged procedure will be described using the retrospective dataset. | Through study completion, an average of 1 year | |
| Secondary | Mortality | The mortality rate after treatment will be described using the retrospective dataset. | Through study completion, an average of 1 year | |
| Secondary | Recurrence | The recurrence rate after treatment will be described using the retrospective dataset. | Through study completion, an average of 1 year | |
| Secondary | 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. | Through study completion, an average of 1 year |