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Synovial Fluid Analysis of Intraarticular Elbow Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02878941
Recruitment Status : Recruiting
First Posted : August 25, 2016
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Elbow Fracture Joint Contracture Procedure: Synovial Fluid Analysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Synovial Fluid Analysis of Intraarticular Elbow Fracture
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Elbow Fracture
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
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 Outcome Measures :
  1. metabolite composition of synovial fluid [ Time Frame: time of fracture until surgical fixation (up to 5 weeks after injury) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02878941

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Contact: Carrigan Creech 9196609343
Contact: Maria J Manson 919681991

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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Carrigan Creech, BS    919-660-9343   
Contact: Marc Richard, MD    9196609343   
Principal Investigator: Marc Richard, MD         
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University Identifier: NCT02878941     History of Changes
Other Study ID Numbers: Pro00072559
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Central Nervous System Depressants
Physiological Effects of Drugs