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Surgical Lavage vs Serial Needle Aspiration for Infected Joints

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. Read our disclaimer for details. Identifier: NCT00313365
Recruitment Status : Withdrawn (Study was never started because Dr. Hammerberg left before it could be started.)
First Posted : April 12, 2006
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):
Thomas Moore, Emory University

Brief Summary:
Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury to the joint space could cause the entry of microorganisms, with the potential to cause infection. Septic arthritis refers to the infection of a joint space with microorganisms, usually bacteria. This invasion initiates a process of inflammation and causes irreversible damage to a joint cavity. Patients typically present with pain, swelling, decreased motion, and inability to use the joint. When bacteria enter a joint space, the host immune system responds by concentrating inflammatory cells within the joint. While inflammatory cells serve to eliminate the bacteria, they also produce substances that not only attack bacteria but also could destroy the joint space. These substances are called enzymes, and they could damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone in the process. Because cartilage has a poor ability to cure itself, this process may lead to irreversible damage and chronic joint dysfunction. Studies have found that signs of early joint damage can be found within hours following joint infection. This is true even if antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection. Also, delay in treatment has been related to poor outcome. However, the best method of treating septic arthritis has yet to be determined. Currently, there are two accepted ways for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space in the OR under anesthesia). Antibiotics are also used with these two forms of treatment. Supporters of surgery believe that the most dependable method of eliminating bacteria from a joint space is through arthrotomy (opening the joint with a surgical incision) and lavage (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration support this method because it is quick, does not require opening the joint space, and can be performed without anesthesia.At present, there are no conclusive studies comparing the two techniques. Hopefully, this study will help delineate the best course of management.

Condition or disease Intervention/treatment Phase
Arthritis Septic Procedure: Surgical Lavage (Arthrotomy) Procedure: Arthrocentesis (Serial needle aspiration) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arthrotomy With Irrigation and Debridement Versus Serial Arthrocentesis as Treatment for Septic Arthritis in Adults
Study Start Date : April 2006
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Primary Outcome Measures :
  1. Eradication of infection at 2 months

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:

  • Patients with acute onset of symptoms of less than or equal to two weeks' duration.
  • Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder
  • Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 - 150,000 cells/mm3.)
  • Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures.
  • Monoarticular arthritis

Exclusion Criteria:

  • Gonococcal infections
  • Infected prosthetic joints
  • Adjacent osteomyelitis preceding joint infection
  • Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness
  • Patients that are 17 years old or less.
  • Polyarticular arthritis.

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): NCT00313365

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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
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Principal Investigator: Erick M Hammerberg, MD Emory University
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Responsible Party: Thomas Moore, Professor, Emory University Identifier: NCT00313365    
Other Study ID Numbers: 218-2006
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases