Primary Objective: 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,…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the number of additional interventions needed to
control the infection of the affected joint
Secondary outcome
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 procedure)
The secondary study parameters (follow-up visit at 3 months post-procedure):
- Range-of-motion of the joint
- Mortality
- Patient reported outcome measures
• Return to sports / work
• EQ5D-5L written in Dutch and English
• KOOS, Knee Injury and Osteoarthritis Outcome Score, written in Dutch and
English (for knee)
• FAOS , Foot and Ankle Outcome score, written in Dutch and English (for ankle)
• PROMIS upper extremity, Patient-Reported Outcomes Measurement Information
System, written in Dutch and English (for shoulder, elbow, wrist)
Background summary
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. Whilst it is not clear which treatment strategy is most
effective, there is consensus that urgent drainage and antibiotic treatment is
needed to avert the imminent threat of sepsis and joint destruction. Clinical
assessment, combined with laboratory tests, imaging, and a diagnostic bedside
aspiration are part of the standard diagnostic workup. When there is a
suspicion of a bacterial arthritis, the patient often undergoes surgery, either
arthroscopically or arthrotomy to lavage the joint and take cultures, after
which antibiotics are started. However, surgery requires anaesthesia and
availability of an operation room, potentially causing diagnostic and treatment
delay as well as anaesthesia-related complications.
Recent technical innovation offers the possibility of 2-mm diameter
arthroscopy. This so-called needle arthroscopic system is CE-marked and uses a
(chargeable) tablet for image processing. The needle arthroscope can be
connected to syringes for distention and lavage of the joint. Hence, compared
to standard arthroscopy, only limited tools are needed (no arthroscopy tower),
allowing it to be moved around the hospital. In addition, only small (2-mm)
portals are needed, which might be acceptable for the patient under local
anesthesia. Needle arthroscopy is more commonly used in orthopaedic care
worldwide, both in the operation room and at the patient bedside, under local
anaesthesia. Our research group submitted pilot data on a small cohort (n=11)
of patients that underwent bedside needle arthroscopy for bacterial arthritis
of various joints. Data appears promising and we therefore believe that needle
arthroscopy is a potential valuable new tool to aid diagnosis and lavage of a
joint in a timely fashion, minimizing morbidity from surgery and general
anaesthesia. We therefore aim to further evaluate the effectiveness (in terms
of avoiding additional interventions to control the infection) of needle
arthroscopy in diagnosing and treating suspected bacterial arthritis. In
addition, we will evaluate patient experience, clinical outcomes, adverse
events, potential risk factors for failure of a single needle arthroscopic
lavage, and economic costs.
Study objective
Primary Objective:
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. 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. The failure rate of conventional arthroscopy or
arthrotomy ranges between 8%-38% in the literature.
Secondary Objective(s):
• To evaluate patient experience: numeric rating scale (NRS) questionnaire.
• To evaluate clinical outcome: range of motion of the affected joint, return
to sports/work, EQ5D-5L-, KOOS-, FOAS-, and PROMIS upper
extremity-questionnaire written in Dutch and English.
• To assess major (e.g. death, severe sepsis, ICU admission, persistent
disability or incapacity) and minor (e.g. infection, hematoma, iatrogenic
damage to articular cartilage, iatrogenic neurovascular damage) adverse events
of needle arthroscopy.
• To evaluate the potential risk factors for failure of a single needle
arthroscopic lavage.
• To evaluate associated costs.
Study design
Single centre (departments of Orthopaedic Surgery and Rheumatology & Clinical
Immunology of Amsterdam UMC, locations AMC and VUmc), prospective observational
cohort study of all patients presenting with a clinical suspected bacterial
arthritis of a native joint.
Intervention
All included patients are treated with a joint lavage by needle-arthroscopy
Study burden and risks
Burden & Risk
• Standard risk of (needle) arthroscopy (i.e. infection, hematoma, iatrogenic
damage to articular cartilage, iatrogenic neurovascular damage)
• Subsequent conventional surgery (conventional arthroscopy or arthrotomy) may
be required to control the infection.
• Failure of needle arthroscopy - necessitating conversion to conventional
arthroscopy or arthrotomy - due to for example:
• Need for general/loco-regional anaesthesia (e.g. due to a patient not
tolerating procedure under local anaesthesia).
• Device failure
• Joint not accessible
• Pre- and post-procedure questionnaires
Benefit
• Expected decrease in need for conventional surgery (conventional arthroscopy
or arthrotomy)
• Procedures can be performed with local or regional anesthesia, potentially
minimizing morbidity from general anaesthesia.
• Patients can probably be treated timelier using bedside needle arthroscopic
lavage as compared with conventional arthroscopic or arthrotomy lavage
requiring an operation room and anesthesia.
• Needle arthroscopy gives more information about the affected joint then
(repeated) needle aspiration. In addition, it will be possible to take biopsies
for culture and histology.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
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 (<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
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78387.018.21 |