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Completed

NCT Number: NCT02878941

Synovial Fluid Analysis of Intraarticular Elbow Fracture

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.

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Key information

Conditions

Elbow Fracture Arm Injuries Elbow Fractures Elbow Injuries Fractures, Bone Joint Contracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synovial Fluid Analysis

Procedure

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.

Primary outcomes

  1. metabolite composition of synovial fluid

    Time frame: time of fracture until surgical fixation (up to 5 weeks after injury)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 25, 2016
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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