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

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ClinicalTrials.gov Identifier: NCT01073124
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Traumatic Knee Arthrotomy Procedure: Saline Load Test

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies
Study Start Date : May 2008
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Volume (mm) injected at time of outflow [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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