Surgical Lavage vs Serial Needle Aspiration for Infected Joints

This study has been withdrawn prior to enrollment.
(Study was never started because Dr. Hammerberg left before it could be started.)
Sponsor:
Information provided by (Responsible Party):
Thomas Moore, Emory University
ClinicalTrials.gov Identifier:
NCT00313365
First received: April 10, 2006
Last updated: September 23, 2013
Last verified: September 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Arthrotomy With Irrigation and Debridement Versus Serial Arthrocentesis as Treatment for Septic Arthritis in Adults

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Eradication of infection at 2 months

Enrollment: 0
Study Start Date: April 2006
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00313365

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Erick M Hammerberg, MD Emory University
  More Information

No publications provided

Responsible Party: Thomas Moore, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00313365     History of Changes
Other Study ID Numbers: 218-2006
Study First Received: April 10, 2006
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014