- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00643487
In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The infrapatellar plica (IPP) of the human knee is vestigial remnant of the embryologic division between the medial and lateral compartments of the knee, present in 85.5% of knees1, felt by some to be of no clinical significance other than acting as a block to visualization an movement during arthroscopy.2 S.J. Kim 3,4, C.R. Boyd 5, and B. Demirag 2006 have documented successful relier of anterior knee pain after resection of the IPP. This study seeks to assess the relationship between knee motion, activation of the extensor apparatus, and the IPP, in essence, the kinematics of the contents of the anterior compartment of the knee. The hypothesis to be evaluated is:
the infrapatellar plica is a structure of fundamental biomechanical significance, allowing the transmission of force from the extensor apparatus to the distal femur through the fat pad, and acting as a restraint and a modulator of fad pad mobility.
Subjects will be identified by the PI at their office visit. The subject will be consented. The consent will be discussed and verified in a second office visit before surgery. The subject will undergo arthroscopy specifically directed toward identifying and treating known pathology. Once this is finished, if an IPP is present, it will be injected with radiographic contrast material. A series of maneuvers will be performed involving passive and active motion of the knee and active contraction of the quadriceps apparatus. Videotape recording and fluoroscopy will be undertaken. The plica will be removed. Another fluoroscopy will be performed. The patient will be followed according to the standard practice for arthroscopy and the defined pathology.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Syracuse, New York, United States, 13202
- SUNY Upstate Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Inclusion:
Healthy subject >18 years of age, skeletally mature Pending knee joint arthroscopy.
Exclusion:
Active infection
Description
must be Healthy subject must be >18 years of age, skeletally mature must bePending knee joint arthroscopy.
may not have Active infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
observation of the behavior of the infrapatellar plica
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Local anesthesia using bupivicaine will be initiated.
The IPP, if present will be injected with contrast material.
In order to minimize discomfort, lidocaine 1%, in as small a volume as possible, will be injected into the fat pad under direct vision to avoid any intra-articular damage from the #25 needle.
Radiographic visualization will be verified and the knee taken through a full range of passive and active exercises.
Active quadriceps contraction in the subject will be performed at 0, 15, 30 60 and 90 degrees of flexion.
In so far as is technically possible, the behavior of the IPP will be videotaped and recorded on lateral fluoroscopy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Successful Recording.
Time Frame: During procedure, on average one hour.
|
Observe the behavior of the IPP of the knee by fluoroscopy.
A complete recording was obtained in 2 patients: this implied that the plica,central body, and fat pad were visualized.
The patients then completed a series of manouevres which demonstrated the mechanical behavior of the infrapatellar plica-fat pad complex.
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During procedure, on average one hour.
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Collaborators and Investigators
Investigators
- Principal Investigator: Thomas V Smallman, MD, State University of New York - Upstate Medical University
Publications and helpful links
General Publications
- Kim SJ, Min BH, Kim HK. Arthroscopic anatomy of the infrapatellar plica. Arthroscopy. 1996 Oct;12(5):561-4. doi: 10.1016/s0749-8063(96)90195-4.
- Kim SJ, Choe WS. Pathological infrapatellar plica: a report of two cases and literature review. Arthroscopy. 1996 Apr;12(2):236-9. doi: 10.1016/s0749-8063(96)90019-5.
- Boyd CR, Eakin C, Matheson GO. Infrapatellar plica as a cause of anterior knee pain. Clin J Sport Med. 2005 Mar;15(2):98-103. doi: 10.1097/01.jsm.0000152706.43395.68.
- Demirag B, Ozturk C, Karakayali M. Symptomatic infrapatellar plica. Knee Surg Sports Traumatol Arthrosc. 2006 Feb;14(2):156-60. doi: 10.1007/s00167-005-0643-8. Epub 2005 Jul 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Infrapatellar Plica
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