Accuracy of the Transpatellar Tendon Approach to Knee Arthrocentesis
This study has been completed.
Sponsor:
Denver Health and Hospital Authority
Information provided by (Responsible Party):
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00888368
First received: April 23, 2009
Last updated: July 11, 2012
Last verified: July 2012
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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 More Information
No publications provided
| Responsible Party: | Denver Health and Hospital Authority |
| ClinicalTrials.gov Identifier: | NCT00888368 History of Changes |
| Other Study ID Numbers: | DHMC07-0387 |
| Study First Received: | April 23, 2009 |
| Last Updated: | July 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 16, 2013