Surgical Lavage Vs Serial Needle Aspiration for Infected Joints - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00313365

Purpose

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	Intervention	Phase
Arthritis Septic	Procedure: Surgical Lavage (Arthrotomy) Procedure: Arthrocentesis (Serial needle aspiration)	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Arthrotomy With Irrigation and Debridement Versus Serial Arthrocentesis as Treatment for Septic Arthritis in Adults

Further study details as provided by Emory University:

Primary Outcome Measures:

Eradication of infection at 2 months

Estimated Enrollment:	200
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313365

Contacts

Contact: Maria Guerrero-Bejarano, MD

404 778 1566

maria.guerrero@emoryhealthcare.org

Locations

United States, Georgia
Grady Memorial Hospital	Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Erick M Hammerberg, MD

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Erick M Hammerberg, MD

Emory University

More Information

Study ID Numbers:	218-2006
Study First Received:	April 10, 2006
Last Updated:	April 11, 2006
ClinicalTrials.gov Identifier:	NCT00313365
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on January 16, 2009