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

Primary Purpose

Traumatic Knee Arthrotomy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Saline Load Test

About this trial

This is an interventional diagnostic trial for Traumatic Knee Arthrotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Saline

Dilute Methylene Blue Dye

Arm Description

Normal Saline injected intraarticularly into the knee joint

1 ml methylene blue dye per 500 ml normal saline injected intraarticularly into the knee

Outcomes

Primary Outcome Measures

Volume (mm) injected at time of outflow

Secondary Outcome Measures

Full Information

NCT ID

NCT01073124

First Posted

February 22, 2010

Last Updated

August 17, 2016

Sponsor

United States Naval Medical Center, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT01073124

Brief Title

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

Official Title

Sensitivity of the Saline Load Test With and Without Methylene Blue Dye in the Diagnosis of Traumatic Knee Arthrotomies

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Knee Arthrotomy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal Saline

Arm Type

Active Comparator

Arm Description

Normal Saline injected intraarticularly into the knee joint

Arm Title

Dilute Methylene Blue Dye

Arm Type

Experimental

Arm Description

1 ml methylene blue dye per 500 ml normal saline injected intraarticularly into the knee

Intervention Type

Procedure

Intervention Name(s)

Saline Load Test

Intervention Description

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.

Primary Outcome Measure Information:

Title

Volume (mm) injected at time of outflow

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul D Metzger, MD

Organizational Affiliation

United States Naval Medical Center, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

Naval Medical Center San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92134

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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