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

NCT03784235 | Completed

• 1 other identifier: BFH_NaF-PET
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 18F NaF-PET/CT uptake

  Assessed before and after an acute loading programme (on the same day).

• Regions of abnormal tracer uptake

  Cross sectional assessment at baseline, i.e., before the loading programme

Other Outcomes (1)

• 18F NaF-PET/CT uptake and pain intensity, pain localization and physical function.

  Cross sectional assessment at baseline, i.e., before the loading programme

Interventions

18F NaF-PET/CT and cone beam CT scans OTHER

Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg Hospital

København NV, 2400, Denmark

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 21, 2018
• Study Start: January 2, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)