Synovial Fluid Analysis of Intraarticular Elbow Fracture

NCT02878941 | Completed

• 1 other identifier: Pro00072559
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elbow Fracture; Joint Contracture

Outcome Measures

Primary Outcomes (1)

• metabolite composition of synovial fluid

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

Study Arms (1)

Elbow Fracture

OTHER

Patients with an intraarticular elbow fracture and/or dislocation. Synovial fluid from the injured elbow will be obtained during the subject's emergency department encounter by one of the Chief Residents or Attending surgeon as part of standard of care procedures for pain control-related injection and aspiration. Patients with an intraarticular elbow fracture and/or dislocation receive an intraarticular elbow injection with anesthetic (i.e. lidocaine or marcaine) to provide analgesia for elbow range of motion testing and orthopaedic reduction maneveuers as the current standard of care. The patients would be asked to consent for 2 elbow joint aspirations: 1.Aspiration of the injured elbow at time of surgical fracture fixation; 2.Aspiration of the uninjured elbow at time of surgical fracture fixation.

Procedure: Synovial Fluid Analysis

Interventions

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.

Elbow Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Intraarticular elbow fracture (humerus, radial head and/or ulna fracture)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: August 25, 2016
• Study Start: May 1, 2017
• Primary Completion: March 6, 2019
• Study Completion: May 17, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-01

Locations

US (1)