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

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ClinicalTrials.gov Identifier: NCT03784235
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Rudi Neergaard Hansen, University Hospital Bispebjerg and Frederiksberg

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Patellofemoral Pain Syndrome Anterior Knee Pain Syndrome 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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 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)
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021
Groups and Cohorts
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Intervention Details:
  • Other: 18F NaF-PET/CT and cone beam CT scans
    Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans

Outcome Measures
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Primary Outcome Measures :
  1. 18F NaF-PET/CT uptake [ 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


Secondary Outcome Measures :
  1. 18F NaF-PET/CT uptake [ 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

  2. Regions of abnormal tracer uptake [ 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


Other Outcome Measures:
  1. 18F NaF-PET/CT uptake and pain intensity, pain localization and physical function. [ 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784235


Contacts
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Contact: Rudi N. Hansen, MSc. +4528104577 rudi.hansen@regionh.dk
Contact: Christian Couppé, PhD. +4560660825 christian.couppe@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
København NV, Denmark, 2400
Contact: Rudi Hansen, M.Sc.    +4528104577    rudihansen@ymail.com   
Sponsors and Collaborators
University Hospital Bispebjerg and Frederiksberg
More Information
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Responsible Party: Rudi Neergaard Hansen, PT, MSc., University Hospital Bispebjerg and Frederiksberg
ClinicalTrials.gov Identifier: NCT03784235    
Other Study ID Numbers: BFH_NaF-PET
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
 Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases