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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 (Responsible Party):
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01073124
First received: February 22, 2010
Last updated: August 17, 2016
Last verified: August 2016
  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 [ Time Frame: 1 month ] [ 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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: United States 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: August 17, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on September 30, 2016