Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE October 31, 2017
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE January 1, 2017
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Superiority of Method of arthrocentesis [ Time Frame: 1 day ]
Number of attempts until successful arthrocentesis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Success of method [ Time Frame: 1 day ]
Completion of arthrocentesis after three attempts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
Official Title  ICMJE Ultrasound Guided Versus Landmark Guided Small & Medium Joint Arthrocentesis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Effusion Joint
Intervention  ICMJE Procedure: Arthrocentesis
Athrocentesis
Study Arms  ICMJE
  • Active Comparator: Ultrasound Guided Arthrocentesis
    The patients in this group will have ultrasound guided arthrocentesis.
    Intervention: Procedure: Arthrocentesis
  • Active Comparator: Landmark Guided Arthrocentesis
    The patients in this group will have landmark guided arthrocentesis.
    Intervention: Procedure: Arthrocentesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03327584
Other Study ID Numbers  ICMJE 24623
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ryan C Gibbons, MD Lewis Katz School of Medicine at Temple University
PRS Account Temple University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP