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Operative and Non-operative Treatment of Traumatic Arthrotomies

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ClinicalTrials.gov Identifier: NCT02841644
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Hsu, Atrium Health

Brief Summary:
For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the joint capsule require formal irrigation and debridement in the operating room to minimize the risk of developing septic complications. The literature supporting this practice is sparse and stems primarily from wartime injuries that may not be generalizable to the smaller, less contaminated arthrotomies seen in the civilian population. Despite the classical teaching of all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating room, numerous surgeons around the country are beginning to treat small traumatic arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment as well as incidence of adverse events, such as the development of septic arthritis, in patients undergoing operative and non-operative treatment of traumatic arthrotomies.

Condition or disease
Traumatic Arthrotomy

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Operative and Non-operative Treatment of Traumatic Arthrotomies: A Prospective Observational Study
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Group/Cohort
Traumatic Arthrotomy
Patient diagnosed with traumatic arthrotomy.



Primary Outcome Measures :
  1. Cost of treatments [ Time Frame: 12 months ]
    To compare the cost of medical care in patients with traumatic arthrotomies treated with surgical irrigation and debridement versus non-operative treatment with local wound care


Secondary Outcome Measures :
  1. Superficial wound infection [ Time Frame: 12 months ]
    To determine the incidence of developing a septic arthritis and other infections in patients treated operatively or non-operatively treated traumatic arthrotomy.

  2. Pain [ Time Frame: 12 months ]
    To determine pain levels in patients treated operatively versus non-operatively traumatic arthrotomy.

  3. Return to work or previous level of activity [ Time Frame: 12 months ]
    To determine return to work or previous level activity in patients treated operatively versus non-operatively traumatic arthrotomy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient 18 years and older with a traumatic arthrotomy
Criteria

Inclusion Criteria:

  • Any patient 18 and older with a traumatic arthrotomy (of any major joint) confirmed by saline load test
  • Direct visualization of a capsular rent or intra-articular contents, or air in the joint on CT or radiographs.

    a. Major Joints Include: i. Knee ii. Elbow iii. Wrist iv. Shoulder v. Hip vi. Ankle

Exclusion Criteria:

  • Patients who will have severe problems with maintaining follow-up

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 ClinicalTrials.gov identifier (NCT number): NCT02841644


Contacts
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Contact: Christine Churchilll, MA 704-355-6947 Christine.Churchill@carolinashealthcare.org
Contact: Rachel Seymour, PhD 704-355-6969 Rachel.Seymour@carolinashealthcare.org

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Paul Stringer, B.S    859-218-3138    paul.stringer@uky.edu   
Principal Investigator: Paul E Matuszewski, MD         
United States, North Carolina
Carolinas Medical Center- Main Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Rachel Seymour, PhD    704-355-6969    Rachel.Seymour@carolinashealthcare.org   
Contact: Christine Churchill, MA    704-355-6947    Christine.Churchill@carolinashealthcare.org   
Principal Investigator: Joseph Hsu, MD         
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Stephanie L Tanner, MS    864-455-1303    stanner@ghs.org   
Contact: , MS         
Principal Investigator: Kyle Jeray, MD         
United States, Texas
The University of Tennessee Health Science Center Recruiting
Memphis, Texas, United States, 38163
Contact: Sara Johnson, RN    901-545-7398    sejohnson@regionalonehealth.org   
Principal Investigator: John C Weinlein, MD         
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Joseph Hsu, MD Atrium Health

Publications:

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Responsible Party: Joseph Hsu, Orthopaedic Traumatologist, Atrium Health
ClinicalTrials.gov Identifier: NCT02841644     History of Changes
Other Study ID Numbers: 04-15-05E
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided