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NCT02878941 Clinical Trial

Synovial Fluid Analysis of Intraarticular Elbow Fracture

Elbow Fracture Clinical Trial

Official title:
Synovial Fluid Analysis of Intraarticular Elbow Fracture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02878941
Other study ID # Pro00072559
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date May 17, 2020

Study information
Verified date January 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to obtain and compare bilateral elbow joint synovial fluid from patients with unilateral intraarticular elbow fracture and a contralateral healthy appearing elbow joint. The synovial fluid samples will undergo several forms of analysis for metabolites and proteins. Matched-pair statistical analysis will be performed to determine the metabolites and proteins that may play the greatest role in development of joint contracture.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date May 17, 2020
Est. primary completion date March 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older

- Intraarticular elbow fracture (humerus, radial head and/or ulna fracture)

Exclusion Criteria:

- Age <18 years

- Open elbow fracture

- Bilateral elbow fractures

- Patients with history of osteomyelitis of elbow

- Inflammatory arthropathy (ie. Rheumatoid arthritis)

- Prior surgery on fractured elbow

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Synovial Fluid Analysis
Synovial fluid aspiration (act of using an 18 gauge needle to obtain synovial fluid from the elbow) in the emergency room for patients with the eligible elbow fracture (as defined in inclusion/exclusion criteria) is performed in conjunction with the anesthetic injection as part of standard of care. The elbow will be prepped as per usual for the anesthetic injection. An 18 gauge needle will be inserted through a lateral approach. The subject's elbow will be aspirated. The syringe with the aspirate would be removed from the needle while the needle would remain in the subject's elbow joint. The syringe with anesthetic would then be connected to the needle, and the anesthetic would be injected into the elbow joint. Therefore, no risks from a separate aspiration would be conferred to the patient.

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary metabolite composition of synovial fluid time of fracture until surgical fixation (up to 5 weeks after injury)
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