Bispebjerg Hospital
København NV, 2400, Denmark
NCT Number: NCT03784235
This study aims to examine whether individuals with unilateral patellofemoral pain (PFP) have increased subchondral bone remodelling and thus increased 18F Sodium Fluoride (18F-NaF) uptake in the painful knee compared to the opposite knee measured by simultaneous positron emission tomography and computed tomography (PET/CT) and to examine whether the increased uptake is associated with pain intensity, with patient-reported function and with pain localization. Furthermore we aim to investigate the effect of an acute patellofemoral loading bout on the bone remodelling.
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Notify Me18 year and older
All sexes
Observational
København NV, 2400, Denmark
Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition mainly affecting younger people, causing pain, physical disability, and reduced quality of life. The cause of PFP is still unknown. It is, i.e., unclear whether there is a link between PFP and changes in the cartilaginous (subchondral) bone in the joint between the patella and the femur.
Our goals are to use 18F NaF PET/CT to evaluate whether subjects with unilateral patellofemoral pain exhibit elevated bone metabolic activity in the painful knee compared to the pain free knee and to determine whether bone metabolic activity correlates with pain intensity and location of pain. Furthermore, we aim to investigate the effects of acute loading on the bone metabolic activity.
The primary objective of this cross-sectional study is to assess whether patients with unilateral PFP have increased bone metabolic activity in the painful knee compared to the pain free knee. We will assess quantitative parameters indicative of bone metabolic activity (Standardized Uptake Value (SUV) and kinetic data) and compare values between the painful knee and the pain free knee. The secondary objectives are to 1) determine whether a bout of single leg weight bearing knee bends standing on a wedge result in increased bone metabolic activity acutely in the painful knee compared to the pain free knee, and 2) identify "hot" regions of abnormal tracer uptake and compare area and SUV values between the painful knee and the pain free knee.
An explorative objective is to determine the correlation between bone metabolic activity and pain intensity and location of pain.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans
Time frame: Cross sectional assessment at baseline, i.e., before the loading programme.
Difference between painful knee and contralateral knee in mean, peak and maximum Standardized Uptake Value (SUV) and in kinetic parameters
Time frame: Assessed before and after an acute loading programme (on the same day).
Response to acute patellofemoral joint loading in mean, peak and maximum SUV and in kinetic parameters. The outcome represents changes in the parameters from before to after the loading programme
Time frame: Cross sectional assessment at baseline, i.e., before the loading programme
Identify "hot" regions of abnormal tracer uptake and compare area and SUV values between the painful knee and the pain free knee
Time frame: Cross sectional assessment at baseline, i.e., before the loading programme
Correlation between tracer uptake parameters and pain intensity measured by pain algometry, pain localization measured by pain drawings and physical function measured by the Anterior Knee Pain Scale
University Hospital Bispebjerg and Frederiksberg
Other
Study of Subchondral Bone Remodeling With 18F NaF-PET / CT in Patients With Patellofemoral Pain. A Substudy for: Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Patellofemoral Pain: a Pragmatic Randomised Trial (the COMPETE Trial)
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