Back to resultsSynovial Fluid Analysis of Intraarticular Elbow Fracture
Primary Purpose
Elbow Fracture, Joint Contracture
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synovial Fluid Analysis
Sponsored by
About this trial
This is an interventional basic science trial for Elbow Fracture
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Elbow Fracture
Arm Description
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.
Outcomes
Primary Outcome Measures
metabolite composition of synovial fluid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02878941
Brief Title
Synovial Fluid Analysis of Intraarticular Elbow Fracture
Official Title
Synovial Fluid Analysis of Intraarticular Elbow Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
May 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture, Joint Contracture
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elbow Fracture
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Synovial Fluid Analysis
Intervention Description
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 Measure Information:
Title
metabolite composition of synovial fluid
Time Frame
time of fracture until surgical fixation (up to 5 weeks after injury)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Synovial Fluid Analysis of Intraarticular Elbow Fracture
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