Patellofemoral Pain SyndromeNCT03784235
Bone Metabolic Activity in the Patellofemoral Joint in Patients With Unilateral PFP
An observational study of Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- What is being tested?
- 18F NaF-PET/CT and cone beam CT scans
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jan 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (n = 30) with unilateral anterior knee pain / PFP (3> 10 NRS) will be included from the main study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of head injury or vestibular disorder within the last 6 months
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- 18F NaF-PET/CT and cone beam CT scans
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F NaF-PET/CT and cone beam CT scansOther
Cross sectional measures of 18F NaF-PET/CT and cone beam CT scans
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Cross sectional assessment at baseline, i.e., before the loading programme.
Secondary outcomes (2)
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
Measured: 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
Measured: Cross sectional assessment at baseline, i.e., before the loading programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start2 Jan 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudi Neergaard Hansen, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784235
- Sponsor's protocol ID
- BFH_NaF-PET
- Status last verified
- May 2022
- First submitted
- 17 Dec 2018
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03784235
- Acronym / sponsor ID
- BFH_NaF-PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (n = 30) with unilateral anterior knee pain / PFP (3> 10 NRS) will be included from the main study.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F NaF-PET/CT and cone beam CT scansCross sectional measures of 18F NaF-PET/CT and cone beam CT scans | Other | – |
Primary outcome
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
2 secondary outcomes
18F NaF-PET/CT uptake
Time frame: Assessed before and after an acute loading programme (on the same day).
Regions of abnormal tracer uptake
Time frame: Cross sectional assessment at baseline, i.e., before the loading programme
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F NaF-PET/CT uptake (time frame: Cross sectional assessment at baseline, i.e., before the loading programme.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.