Anterior Knee Pain SyndromeNCT00643487
In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee
An observational study of Anterior Knee Pain Syndrome, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- observation of the behavior of the infrapatellar plica
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion: Healthy subject >18 years of age, skeletally mature Pending knee joint arthroscopy. Exclusion: Active infection
must be Healthy subject must be >18 years of age, skeletally mature must bePending knee joint arthroscopy.
may not have Active infection
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13202
About this study
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.
Read the 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.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- observation of the behavior of the infrapatellar plica
- Keywords
- Knee physiology, Anterior compartment knee, Infrapatellar plica, Ligamentum mucosum, Enthesis organ, Fat pad of the knee, Patellofemoral kinematics
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation of the behavior of the infrapatellar plicaProcedure or surgery
Also called Knee surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | observation of the behavior of the infrapatellar plica Receives: Procedure: observation of the behavior of the infrapatellar plica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Recording.
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.
Measured: During procedure, on average one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Smallman, State University of New York - Upstate Medical University
- Investigators
- Thomas V Smallman, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643487
- Sponsor's protocol ID
- Infrapatellar Plica
- Status last verified
- Apr 2018
- First submitted
- 4 Mar 2008
- Last updated
- 24 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 8902130Kim 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.
PubMed 8777004Boyd 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.
PubMed 15782055Demirag 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.
PubMed 16059707
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Arthroscopic Behavior of the Infrapatellar Plica of the Knee
- ClinicalTrials.gov ID
- NCT00643487
- Acronym / sponsor ID
- Infrapatellar Plica
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Knee physiology, Anterior compartment knee, Infrapatellar plica, Ligamentum mucosum, Enthesis organ, Fat pad of the knee, Patellofemoral kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 18 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: observation of the behavior of the infrapatellar plicaobservation of the behavior of the infrapatellar plica |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion: Healthy subject >18 years of age, skeletally mature Pending knee joint arthroscopy. Exclusion: Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation of the behavior of the infrapatellar plicaAlso: Knee surgeryLocal 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. | Procedure or surgery | 1 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8902130Kim 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.
- Background: PubMed 8777004Kim 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.
- Background: PubMed 15782055Boyd 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.
- Background: PubMed 16059707Demirag 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas V Smallman, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Knee Pain Syndrome, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Recording. (time frame: During procedure, on average one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643487, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.