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Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327584
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Effusion Joint Procedure: Arthrocentesis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Ultrasound Guided Arthrocentesis
The patients in this group will have ultrasound guided arthrocentesis.
Procedure: Arthrocentesis
Athrocentesis

Active Comparator: Landmark Guided Arthrocentesis
The patients in this group will have landmark guided arthrocentesis.
Procedure: Arthrocentesis
Athrocentesis




Primary Outcome Measures :
  1. Superiority of Method of arthrocentesis [ Time Frame: 1 day ]
    Number of attempts until successful arthrocentesis


Secondary Outcome Measures :
  1. Success of method [ Time Frame: 1 day ]
    Completion of arthrocentesis after three attempts



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients who require an arthrocentesis of a small and/or medium joint (defined previously)

Exclusion Criteria:

  • Coagulopathic patients
  • Patients on anticoagulants
  • Patients with cellulitis overlying the joint.
  • Patients with artificial joints
  • Adults Unable to Consent
  • Vulnerable Populations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327584


Locations
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United States, Pennsylvania
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Investigators
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Principal Investigator: Ryan C Gibbons, MD Lewis Katz School of Medicine at Temple University

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03327584    
Other Study ID Numbers: 24623
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrarthrosis
Joint Diseases
Musculoskeletal Diseases