Synovial Fluid Analysis of Intraarticular Elbow Fracture

Not Applicable

Completed

• Conditions: Elbow Fracture; Joint Contracture
• Interventions: Procedure: Synovial Fluid Analysis

• Registration Number: NCT02878941
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Study Start: 2017-05-01
• Primary Completion: 2019-03-06
• Status Verified: 2020-01
• Study Completion: 2020-05-17
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elbow Fracture	Synovial Fluid Analysis	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.

Primary Outcome Measures

Name	Time	Method
metabolite composition of synovial fluid	time of fracture until surgical fixation (up to 5 weeks after injury)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States