NCT04742127

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

4.8 years

First QC Date

January 29, 2021

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Population of patients who would benefit from a staged procedure

    Through study completion, an average of 1 year

  • Prevalence of failure of initial debridement

    Through study completion, an average of 1 year

  • Prevalence of staged procedure

    Through study completion, an average of 1 year

  • Mortality

    Through study completion, an average of 1 year

  • Recurrence

    Through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

Patients with septic arthritis of the native hip

Diagnostic Test: Single surgical debridement

Interventions

To describe the clinical factors associated with failure of a single surgical debridement in patients with septic arthritis of the native hip.

Patients with septic arthritis of the native hip

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with septic arthritis of the native hip treated at UZ Leuven in the last decade

You may qualify if:

  • 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

You may not qualify if:

  • \- History of arthroplasty of the hip in the affected joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 5, 2021

Study Start

January 26, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations