arthritis bacterial arthritis
Conditions
Interventions
All included patients are treated with a joint lavage by needle-arthroscopy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients with clinical suspicions of bacterial arthritis of a native joint of the shoulder, elbow, wrist, knee or ankle who provided informed consent to be included in this study. - Patients are above 18 years of age - Is able to understand Dutch or English language
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - A foreign body in the affected joint (e.g. screw, prothesis, anchor, suture) - History of arthroplasty in the affected joint - Recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the number of additional interventions needed to control the infection of the affected joint | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters (procedure & admission): - Failure of needle arthroscopy due to e.g.: • Need for conversion to general or loco-regional anesthesia (e.g. due to the patient not tolerating procedure under local anesthesia) • Device failure • Joint not accessible with needle arthroscopy - The number and nature of adverse events within 3 months • Local nerve damage • Bleeding that requires an additional surgical or radiological-intervention procedure to control the bleeding • Wound infection • Any adverse events during hospitalization (e.g. pneumonia, thrombosis, myocardial infarction, urinary tract infection, etcetera) that requires an additional surgical procedure, radiological-intervention procedure or medical intervention (e.g. antibiotic treatment) to control the adverse event. - The number and nature of serious adverse events within 3 months • Death • Prolongation of hospitalization • Severe sepsis • ICU admission • Disability or permanent damage (i.e. resulted in a substantial disruption of a person*s ability to conduct normal life functions, resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient*s body function, physical activities and/or quality of life). • Other serious adverse events (i.e. the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes. - Length of hospital stay (as measured as the time between arrival and discharge) - Time of the intervention (as measured as the time between the camera enters into the joint and the camera goes out of the joint at the end of the procedure) - Time between patient presentation and needle arthroscopic procedure - Patient experience during the procedure, as measured with a numeric rating scale (where patients are asked to circle the number between 0 and 10 that fits best to their pain intensity during the proc | — |
Countries
Netherlands
Outcome results
None listed