NCT03327584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

October 27, 2017

Last Update Submit

January 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Superiority of Method of arthrocentesis

    Number of attempts until successful arthrocentesis

    1 day

Secondary Outcomes (1)

  • Success of method

    1 day

Study Arms (2)

Ultrasound Guided Arthrocentesis

ACTIVE COMPARATOR

The patients in this group will have ultrasound guided arthrocentesis.

Procedure: Arthrocentesis

Landmark Guided Arthrocentesis

ACTIVE COMPARATOR

The patients in this group will have landmark guided arthrocentesis.

Procedure: Arthrocentesis

Interventions

Athrocentesis

Landmark Guided ArthrocentesisUltrasound Guided Arthrocentesis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hydrarthrosis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ryan C Gibbons, MD

    Lewis Katz School of Medicine at Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2017

First Posted

October 31, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations