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)

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome
• Intervention / Treatment: Other: 18F NaF-PET/CT and cone beam CT scans

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Denmark
  • København NV, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults (n = 30) with unilateral anterior knee pain / PFP (3> 10 NRS) will be included from the main study.

Description

Inclusion Criteria:

• A clinical diagnosis of PFP in at least one knee confirmed by an experienced sports medicine doctor.
• Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.
• Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.

• Pain in the anterior knee associated with at least 3 of the following:

  • During or after activity
  • Prolonged sitting
  • Stair ascent or descent
  • Squatting

Exclusion Criteria:

• Meniscal or other intra-articular injury
• Cruciate or collateral ligament laxity or tenderness
• Patellar tendon, iliotibial band, or pes anserine tenderness
• Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
• History of recurrent patellar subluxation or dislocation
• History of surgery to the knee joint
• History of head injury or vestibular disorder within the last 6 months
• Pregnancy
• Breastfeeding

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F NaF-PET/CT uptake	Difference between painful knee and contralateral knee in mean, peak and maximum Standardized Uptake Value (SUV) and in kinetic parameters	Cross sectional assessment at baseline, i.e., before the loading programme.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F NaF-PET/CT uptake	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	Assessed before and after an acute loading programme (on the same day).
Regions of abnormal tracer uptake	Identify "hot" regions of abnormal tracer uptake and compare area and SUV values between the painful knee and the pain free knee	Cross sectional assessment at baseline, i.e., before the loading programme

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F NaF-PET/CT uptake and pain intensity, pain localization and physical function.	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	Cross sectional assessment at baseline, i.e., before the loading programme

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (ACTUAL): December 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 27, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: BFH_NaF-PET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No