Effusion JointNCT03327584
Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
A study testing Arthrocentesis in people with Effusion Joint, run by Temple University at 1 site in United States.
Trial summary
Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. Ultrasound (US) and landmark (LM) small \& medium joint arthrocentesis are both performed within the clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Effusion Joint
- What is being tested?
- Arthrocentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who require an arthrocentesis of a small and/or medium joint (defined previously)
Who cannot join
- Coagulopathic patients
- Patients on anticoagulants
- Patients with cellulitis overlying the joint.
- Patients with artificial joints
- Adults Unable to Consent
- Vulnerable Populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, 19140
About this study
Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. Ultrasound (US) and landmark (LM) small \& medium joint arthrocentesis are both performed within the clinical setting. Both techniques are considered standard of care. Selection of which technique to use is dependent upon the physician's preference. There is currently limited data comparing the two methods. The investigators hope to determine if one modality is more effective in terms of success rate, number of attempts, and time to complete the procedure.
Read the detailed description
Patients presenting to the Emergency Department who are 18 years old or older, who do not belong to a vulnerable group, requiring small or medium joint arthrocentesis will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts to tap the joint, success rate, and time for procedure to be completed. The arthrocentesis will be performed by PGY-3 residents only. A 21 gauge needle will be used for the arthrocentesis.
- Conditions
- Effusion Joint
- Being tested
- Arthrocentesis
- Medical subject headings
- Hydrarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
Athrocentesis
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Arthrocentesis | Active comparator | The patients in this group will have ultrasound guided arthrocentesis. Receives: Procedure: Arthrocentesis |
| Landmark Guided Arthrocentesis | Active comparator | The patients in this group will have landmark guided arthrocentesis. Receives: Procedure: Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of Method of arthrocentesis
Number of attempts until successful arthrocentesis
Measured: 1 day
Secondary outcomes (1)
Success of method
Completion of arthrocentesis after three attempts
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effusion JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan C Gibbons, MD, Principal investigator, Lewis Katz School of Medicine at Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327584
- Sponsor's protocol ID
- 24623
- Status last verified
- Jan 2020
- First submitted
- 27 Oct 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gibbons RC, Zanaboni A, Genninger J, Costantino TG. Ultrasound-versus landmark-guided medium-sized joint arthrocentesis: A randomized clinical trial. Acad Emerg Med. 2022 Feb;29(2):159-163. doi: 10.1111/acem.14396. Epub 2021 Oct 23.
PubMed 34608713
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
- ClinicalTrials.gov ID
- NCT03327584
- Acronym / sponsor ID
- 24623
- Conditions
- Effusion Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Arthrocentesis is the removal of synovial fluid for analysis of pathologic processes. Small \& medium joint arthrocentesis will be defined as the following joints: elbow, wrist, finger, ankle and toe. Ultrasound (US) and landmark (LM) small \& medium joint arthrocentesis are both performed within the clinical setting. Both techniques are considered standard of care. Selection of which technique to use is dependent upon the physician's preference. There is currently limited data comparing the two methods. The investigators hope to determine if one modality is more effective in terms of success rate, number of attempts, and time to complete the procedure.
Detailed description
Patients presenting to the Emergency Department who are 18 years old or older, who do not belong to a vulnerable group, requiring small or medium joint arthrocentesis will be included in this trial. The investigators will randomize each patient into LM vs US. Data collected will include number of attempts to tap the joint, success rate, and time for procedure to be completed. The arthrocentesis will be performed by PGY-3 residents only. A 21 gauge needle will be used for the arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Arthrocentesis | Active comparator | Procedure: ArthrocentesisThe patients in this group will have ultrasound guided arthrocentesis. |
| Landmark Guided Arthrocentesis | Active comparator | Procedure: ArthrocentesisThe patients in this group will have landmark guided arthrocentesis. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who require an arthrocentesis of a small and/or medium joint (defined previously)
Key exclusion criteria (6 listed)
- Coagulopathic patients
- Patients on anticoagulants
- Patients with cellulitis overlying the joint.
- Patients with artificial joints
- Adults Unable to Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthrocentesisAthrocentesis | Procedure or surgery | Landmark Guided Arthrocentesis, Ultrasound Guided Arthrocentesis |
Primary outcome
Superiority of Method of arthrocentesis
Time frame: 1 day
Number of attempts until successful arthrocentesis
1 secondary outcome
Success of method
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 34608713Gibbons RC, Zanaboni A, Genninger J, Costantino TG. Ultrasound-versus landmark-guided medium-sized joint arthrocentesis: A randomized clinical trial. Acad Emerg Med. 2022 Feb;29(2):159-163. doi: 10.1111/acem.14396. Epub 2021 Oct 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan C Gibbons, MD principal investigator
Lewis Katz School of Medicine at Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis in people with Effusion Joint, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of Method of arthrocentesis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.