Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis - Full Text View

Sponsored by:	Denver Health and Hospital Authority
Information provided by:	Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:	NCT00888368

Purpose

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.

Condition	Intervention
Knee Aspiration	Procedure: Transpatellar Approach Procedure: Suprapatellar

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	January 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Transpatellar Approach: Experimental	Procedure: Transpatellar Approach The transpateller approach for the injection of the dye will be used.
Suprapatellar Approach: Active Comparator	Procedure: Suprapatellar The suprapatellar approach will be used for the injection of the dye.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888368

Locations

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

Sponsors and Collaborators

Denver Health and Hospital Authority

More Information

No publications provided

Responsible Party:	Denver Health Medical Center - Department of Orthopaedics ( Steven Morgan, MD )
Study ID Numbers:	DHMC07-0387
Study First Received:	April 23, 2009
Last Updated:	April 24, 2009
ClinicalTrials.gov Identifier:	NCT00888368 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 07, 2009