Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis

July 11, 2012 updated by: Denver Health and Hospital Authority

The purpose of this study is:

  • To determine the accuracy of intraarticular placement with the transpatellar tendon approach as compared to the suprapatellar approach. Patients undergoing knee arthroscopy will be consented for study of the injection of the fluid into the joint prior to portal placement or commencement of knee replacement. Patients will be randomized to receive injections via the transpatellar tendon or superolateral approach. Using injectable contrast and fluoroscopy, the placement of injections into the knee will be evaluated for accuracy. Injection attempts with contrast fluid that uniformly coats the articular surface on sagittal and coronal radiographs will be counted as successful. A concentration of contrast fluid in extraarticular fat will be counted as a failure.

Hypothesis: The rate of accuracy of intraarticular placement of the needle tip via the transpatellar tendon approach to knee aspiration is greater than that of the superolateral approach.

  • To determine the distribution of contrast material with the transpatellar tendon and superolateral apporaches. Using a previously described evaluation technique of dividing the knee into seven compartments, sagittal and coronal fluoroscopy images will be evaluated to determine the distribution of contrast fluid.

Hypothesis: Contrast injected into the knee via the trasnpatellar tendon approach will penetrate as many compartments of the knee as contrast injected via the superolateral approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • undergoing elective arthroscopic surgery of the knee
  • age greater than 18 years old and less than 80 years old
  • able to consent to a research study

Exclusion Criteria:

  • allergy to contrast dye, iodine or shellfish
  • currently pregnant
  • acute fracture or dislocation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transpatellar Approach
Procedure: Transpatellar Approach
The transpateller approach for the injection of the dye will be used.
Active Comparator: Suprapatellar Approach
Procedure: Suprapatellar
The suprapatellar approach will be used for the injection of the dye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The development of an easier approach to aspirating the knee may lead to improved accuracy of intraarticular needle placement by less experienced practitioners and more "anatomically difficult" knees.
Time Frame: 1 time (intraop)
1 time (intraop)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • DHMC07-0387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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