We hypothesize that the effectiveness of lavage with needle arthroscopy should at least be equal (i.e. non-inferior) to lavage with conventional arthroscopy or arthrotomy based on failure rates reported in the literature.
ID
Bron
Verkorte titel
Aandoening
Bacterial arthritis of a native joint
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To establish the effectiveness of lavage with needle arthroscopy in patients with suspected bacterial arthritis of a native joint. The primary outcome measure is the number of additional
invasive interventions -needle aspiration, needle arthroscopy, conventional arthroscopy, arthrotomy, or other procedure (e.g. resection/amputation/arthrodesis/prosthesis)- needed to
control the infection of the affected joint within 30 days
Achtergrond van het onderzoek
A bacterial infection of a native joint, so-called bacterial or septic arthritis, urgently requires diagnosis and subsequent treatment to control the infection and decrease the risk of joint destruction. Treatment consists of drainage of the affected joint and antibiotic therapy. A large spectrum of techniques to drain the joint has been described; from needle aspiration to
open surgical lavage. Recent technical innovation offers the possibility of 2-mm diameter arthroscopy, so-called needle arthroscopy. Compared to conventional arthroscopy, less
equipment is needed. In addition, only small (2-mm) portals are required, which might be acceptable for the patient under local anaesthesia. Hence, needle arthroscopy might be a
valuable new tool to aid diagnosis and treatment of a bacterial arthritis in a timely fashion, minimizing morbidity from surgery and general anaesthesia. We hypothesise that needle
arthroscopy under local anaesthesia can decrease the need for surgery in patients suspected of a bacterial arthritis of a native joint.
Doel van het onderzoek
We hypothesize that the effectiveness of lavage with needle arthroscopy should at least be equal (i.e. non-inferior) to lavage with conventional arthroscopy or arthrotomy based on failure rates reported in the literature.
Onderzoeksopzet
Baseline
3 - month time point follow-up
Onderzoeksproduct en/of interventie
Needle arthroscopy in patients with a clinical suspicion of bacterial arthritis of a native joint
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
- Presents with a clinical suspicion of bacterial arthritis of a native joint of the
shoulder, elbow, wrist, knee or ankle
- Is able to provide informed consent to be included in this study.
- Is 18 years of age or older
- Is able to understand Dutch or English language
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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, anchor, prosthesis, suture).
- Recent (<3 months) fracture surgery involving arthrotomy with the use of
osteosynthesis material in the affected joint
- Acute traumatic open joint fracture or dislocation
- Local osteomyelitis
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9802 |
| CCMO | NL78387.018.21 |
| OMON | NL-OMON54067 |