In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee

April 20, 2018 updated by: Thomas Smallman, State University of New York - Upstate Medical University
Anterior knee pain has been an enigmatic problem for orthopedic surgeons. Recent studies, as well as the clinical observation of the principle investigator have suggested that arthroscopic resection of the infrapatellar plica (IPP), a vestigial remnant from embryonic development of no known clinical or biological significance, may eliminate this pain. The mechanism whereby this pain is related to the IPP is unclear. This study will document the mechanical behavior of the IPP, its kinematics, as recorded on video among a group of subjects who are undergoing arthroscopy. Radiographic visualization of the observed behavior will be obtained by injection of contrast material, and then fluoroscopic recording of a standard series of motions. The plica will then be resected to avoid any possibility of residual symptoms related to its presence. Further fluoroscopy of the knee without plical attachment, will allow the kinematic behavior to be assessed. The procedure will then be terminated.

Study Overview

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

Observational

Enrollment (Actual)

8

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

    • New York
      • Syracuse, New York, United States, 13202
        • SUNY Upstate Medical University

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
observation of the behavior of the infrapatellar plica
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:
  • Knee surgery

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.
During procedure, on average one hour.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Thomas V Smallman, MD, State University of New York - Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

February 1, 2006

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 26, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

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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