Sensitivity Diagnosing Traumatic Knee Injuries With and Without Injection of Blue Dye Into the Knee Joint

This study has been completed.
Sponsor:
Information provided by:
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01073124
First received: February 22, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The purpose of this study is to determine if adding blue dye improves the saline load test, which is a way to detect a traumatic intraarticular knee injury by injecting normal saline into the knee and looking for outflow through the wound.


Condition Intervention
Traumatic Knee Arthrotomy
Procedure: Saline Load Test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Volume (mm) injected at time of outflow [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Saline
Normal Saline injected intraarticularly into the knee joint
Procedure: Saline Load Test
Intraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml.
Experimental: Dilute Methylene Blue Dye
1 ml methylene blue dye per 500 ml normal saline injected intraarticularly into the knee
Procedure: Saline Load Test
Intraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with diagnosis warranting elective knee arthroscopy

Exclusion Criteria:

  • Pregnant women
  • Decreased knee range of motion (flex < 125, ext <0)
  • Active infection of knee joint
  • history of or current intraarticular knee malignancy
  • history of open traumatic injury of the knee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073124

Locations
United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Paul D Metzger, MD United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: Paul Metzger, MD, LT MC USN, Naval Medical Center San Diego
ClinicalTrials.gov Identifier: NCT01073124     History of Changes
Other Study ID Numbers: NMCSD.2008.0006
Study First Received: February 22, 2010
Last Updated: February 22, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014