AbnormalitiesNCT00978003
Vasti Control of Patellofemoral Kinematics in Asymptomatic Volunteer
An observational study of Abnormalities and Patellofemoral Pain Syndrome, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Patellofemoral pain syndrome is one of the most common knee problems. It is characterized by pain in the front of the knee that is aggravated by deep knee flexion, prolonged sitting, and repetitive movement. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Abnormalities, Patellofemoral Pain Syndrome
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects for this study will be recruited through the Patient Recruitment and Public Liaison (PRPL) office. PRPL will respond to clinical research study inquiries, conduct preliminary screening for the protocol, and refer prospective patients to the Protocol Manager.
Who may be able to join
- Healthy male and female volunteers between the ages of 18 and 55.
- <TAB>
Who cannot join
- Any relevant medical problems (connective tissue problems, active arthritis, etc.)
- Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malaligment, and ligament damage.
- Any serious injury to the joint being studied, previous surgery on the joint being studied or extreme pain at the joint being studied.
- Allergy/hypersensitivity to lidocaine.
- Liver disease.
- Open angle glaucoma.
Show all 13Show fewer
- Cardiac arrhythmias, congenital heart disease.
- G6PD.
- Any female who is pregnant.
- A volunteer will be excluded if they have a contraindication to MR imaging. Examples include:
- Metal within their body, which might be expected to concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (e.g., aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ccular foreign body (e.g. metal shavings, insulin pump).
- A condition, which would preclude them from participating in an MR imaging study (e.g., paralyzed hemidiaphragm, morbid obesity, severe claustrophobia).
- A condition that presents an unnecessary risk to them or their unborn child (e.g., pregnancy, previous surgery of uncertain type, symptoms of pheochromocytoma or insulinoma).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Vasti Control of Patellofemoral Kinematics in Asymptomatic Volunteers
Background:
- Patellofemoral pain syndrome is one of the most common knee problems. It is characterized by pain in the front of the knee that is aggravated by deep knee flexion, prolonged sitting, and repetitive movement. The most widely accepted theory regarding the source of this pain is that a force imbalance around the knee puts extra stress on the area, leading to pain.
- Researchers are interested in learning more about the muscle groups around the knee to better understand the causes of knee pain.
Read more
Objectives:
- To obtain more information on how muscles, tendons, and bones work together to cause motion in the knee, both in the normal state and after immobilizing certain muscles around the knee.
Eligibility:
- Healthy individuals between the ages of 18 and 55, who have no current or chronic muscle, bone, or joint problems and who have no implants or other problems that would prevent them from receiving a magnetic resonance imaging (MRI) scan.
Design:
- This protocol will be carried out over two visits, both of which will involve using standard MRI sequences to look at the knee at rest and in motion.
- The first part will examine the knee under its natural state, with a standard MRI scan of the knee both at rest and in motion.
- The second part will involve temporarily reducing the force producing capabilities of one of the extensor muscles in the knee. To do so, study doctors will inject lidocaine into the muscle, which will temporarily (for approximately 2 hours) block the force producing capacity of this muscle, and then perform the MRI scan....
Read the detailed description
Patellofemoral pain syndrome is one of the most common problems of the knee. It is characterized by anterior knee pain that is aggravated by deep knee flexion, prolonged sitting, and repetitive flexion/extension. The most widely accepted theory in regards to the source of this pain is that a force imbalance around the knee leads to static patellofemoral malalignment and dynamic patellofemoral maltracking. In turn, this malalignment and maltracking lead to elevated joint contact stresses, which ultimately leads to patellofemoral pain. Current understanding of patellofemroal maltracking is typically focused on static 2D alignment (lateral tilt and displacement). Yet, patellofemoreal pain is most often exacerbated during dynamic events and the patella has complete six degrees of freedom in its movement. More recent studies have been able to quantify patellofemoral kinematics during volitional dynamic tasks and demonstrate that the maltracking problem is more complex than originally postulated. Specifically, in patients with patellofemoral pain, altered kinematics are not limited to excessive patellar lateral translation and tilt, but include excessive patellar superior translation along with excessive flexion and varus rotation. Although these results are useful in demonstrating how specific maltracking patterns could lead to patellofemoral pain, they do not present any associations between a potentially altered force balance around the knee and the observed maltracking patterns. Therefore, the overall goal of this work is to determine the specific sources of maltracking patterns in patellofemoral pain. As part of this overall goal, the purpose of this study is to determine how the loss of force in the vasti medialis muscle alters the dynamic control of patellar kinematics.
- Conditions
- Abnormalities, Patellofemoral Pain Syndrome
- Keywords
- Maltracking, Anterior Knee Pain, Knee, Natural History
- Medical subject headings
- Congenital Abnormalities, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Healthy Volunteers | Adults age 18-55. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliminating the force producing capacity of the VM will increase patellar lateral shift, lateral tilt and valgus rotation.
MRI imaging followed by muscle block and ultrasound.
Measured: End of study
Secondary outcomes (1)
The amount of increase in patellar lateral shift, lateral tilt and valgus rotation, seen with the loss of the VM muscle will be correlated with the inferior- superior position of the patella relative to the femur.
MRI imaging followed by muscle block and ultrasound.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study start22 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbnormalitiesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frances T Gavelli, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978003
- Sponsor's protocol ID
- 090217
- Other IDs
- 09-CC-0217
- Status last verified
- 21 Oct 2026
- First submitted
- 15 Sep 2009
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasti Control of Patellofemoral Kinematics in Asymptomatic Volunteers
- ClinicalTrials.gov ID
- NCT00978003
- Acronym / sponsor ID
- 090217
- Conditions
- Abnormalities, Patellofemoral Pain Syndrome
- Keywords
- Maltracking, Anterior Knee Pain, Knee, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 22 Oct 2009 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Patellofemoral pain syndrome is one of the most common knee problems. It is characterized by pain in the front of the knee that is aggravated by deep knee flexion, prolonged sitting, and repetitive movement. The most widely accepted theory regarding the source of this pain is that a force imbalance around the knee puts extra stress on the area, leading to pain.
- Researchers are interested in learning more about the muscle groups around the knee to better understand the causes of knee pain.
Objectives:
- To obtain more information on how muscles, tendons, and bones work together to cause motion in the knee, both in the normal state and after immobilizing certain muscles around the knee.
Eligibility:
- Healthy individuals between the ages of 18 and 55, who have no current or chronic muscle, bone, or joint problems and who have no implants or other problems that would prevent them from receiving a magnetic resonance imaging (MRI) scan.
Design:
- This protocol will be carried out over two visits, both of which will involve using standard MRI sequences to look at the knee at rest and in motion.
- The first part will examine the knee under its natural state, with a standard MRI scan of the knee both at rest and in motion.
- The second part will involve temporarily reducing the force producing capabilities of one of the extensor muscles in the knee. To do so, study doctors will inject lidocaine into the muscle, which will temporarily (for approximately 2 hours) block the force producing capacity of this muscle, and then perform the MRI scan....
Detailed description
Patellofemoral pain syndrome is one of the most common problems of the knee. It is characterized by anterior knee pain that is aggravated by deep knee flexion, prolonged sitting, and repetitive flexion/extension. The most widely accepted theory in regards to the source of this pain is that a force imbalance around the knee leads to static patellofemoral malalignment and dynamic patellofemoral maltracking. In turn, this malalignment and maltracking lead to elevated joint contact stresses, which ultimately leads to patellofemoral pain. Current understanding of patellofemroal maltracking is typically focused on static 2D alignment (lateral tilt and displacement). Yet, patellofemoreal pain is most often exacerbated during dynamic events and the patella has complete six degrees of freedom in its movement. More recent studies have been able to quantify patellofemoral kinematics during volitional dynamic tasks and demonstrate that the maltracking problem is more complex than originally postulated. Specifically, in patients with patellofemoral pain, altered kinematics are not limited to excessive patellar lateral translation and tilt, but include excessive patellar superior translation along with excessive flexion and varus rotation. Although these results are useful in demonstrating how specific maltracking patterns could lead to patellofemoral pain, they do not present any associations between a potentially altered force balance around the knee and the observed maltracking patterns. Therefore, the overall goal of this work is to determine the specific sources of maltracking patterns in patellofemoral pain. As part of this overall goal, the purpose of this study is to determine how the loss of force in the vasti medialis muscle alters the dynamic control of patellar kinematics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Healthy Volunteers | – | –Adults age 18-55. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects for this study will be recruited through the Patient Recruitment and Public Liaison (PRPL) office. PRPL will respond to clinical research study inquiries, conduct preliminary screening for the protocol, and refer prospective patients to the Protocol Manager.
Key inclusion criteria (2 listed)
- <TAB>
Key exclusion criteria (13 listed)
- Any relevant medical problems (connective tissue problems, active arthritis, etc.)
- Any clinical signs of a knee impairment in the joint being studied, including abnormal range of motion, muscle weakness, malaligment, and ligament damage.
- Any serious injury to the joint being studied, previous surgery on the joint being studied or extreme pain at the joint being studied.
- Allergy/hypersensitivity to lidocaine.
- Liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eliminating the force producing capacity of the VM will increase patellar lateral shift, lateral tilt and valgus rotation.
Time frame: End of study
MRI imaging followed by muscle block and ultrasound.
1 secondary outcome
The amount of increase in patellar lateral shift, lateral tilt and valgus rotation, seen with the loss of the VM muscle will be correlated with the inferior- superior position of the patella relative to the femur.
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Frances T Gavelli, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Abnormalities and Patellofemoral Pain Syndrome, run by National Institutes of Health Clinical Center (CC) 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?
The sponsor lists 2 inclusion and 13 exclusion criteria. 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 29 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eliminating the force producing capacity of the VM will increase patellar lateral shift, lateral tilt and valgus rotation. (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.