Surgical Lavage vs Serial Needle Aspiration for Infected Joints

NCT00313365 | Withdrawn Phase 3

• 1 other identifier: 218-2006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Septic

Outcome Measures

Primary Outcomes (1)

• Eradication of infection at 2 months

Interventions

Surgical Lavage (Arthrotomy) PROCEDURE

Arthrocentesis (Serial needle aspiration) PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Erick M Hammerberg, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2006
• First Posted: April 12, 2006
• Study Start: April 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

US (1)