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

NCT ID: NCT01073124

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Knee Arthrotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Normal Saline

Normal Saline injected intraarticularly into the knee joint

Group Type ACTIVE_COMPARATOR

Saline Load Test

Intervention Type PROCEDURE

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.

Dilute Methylene Blue Dye

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

Group Type EXPERIMENTAL

Saline Load Test

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Naval Medical Center, San Diego

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul D Metzger, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

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Naval Medical Center San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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NMCSD.2008.0006

Identifier Type: -

Identifier Source: org_study_id

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