Clinical Trials Directory

Trials / Completed

CompletedNCT03784235

Bone Metabolic Activity in the Patellofemoral Joint in Patients With Unilateral PFP

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)

Status
Completed
Phase
Study type
Observational
Enrollment
27 (actual)
Sponsor
University Hospital Bispebjerg and Frederiksberg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHER18F NaF-PET/CT and cone beam CT scansCross sectional measures of 18F NaF-PET/CT and cone beam CT scans

Timeline

Start date
2019-01-02
Primary completion
2021-12-01
Completion
2021-12-01
First posted
2018-12-21
Last updated
2022-05-31

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT03784235. Inclusion in this directory is not an endorsement.