Patellofemoral Pain SyndromeKarma-4DNCT04732585
Kinematic Assessment of Human Peripheral Joints by Dynamic CT
A study testing Physiotherapy or Surgery in people with Patellofemoral Pain Syndrome and ACL Tear, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Aim of the research project: The entire research project aims to investigate human peripheral joints (knee, foot \& ankle, elbow, wrist \& hand) by dynamic 4D radiographic imaging acquisition during real-time motion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, ACL Tear
- What is being tested?
- Physiotherapy or Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to Sep 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patellar/anterior knee pain, provoked by functional activities such as Squatting, Ascending/Descending stairs, Prolonged sitting, Kneeling, Jumping and/or running.
- ACL that requires surgical reconstruction. Imaging findings of ACL injury (MRI)
Who cannot join
- Metallic implants in the proximity of the knee.
- Affections of the Central Nervous System, including Cerebellar dysfunction, Stroke, ALS and MS, affect the strength, motor control and/or coordination of human joints and produce "abnormal" movement patterns;
- Affections of the Peripheral Nervous System of the lower limb, including Lumbar radiculopathy, Peripheral nerve entrapment and Neuropathy, affect the proprioception and muscle force.
- Pregnant women.
- Inflammatory Conditions
- Hyperlaxity
Show all 14Show fewer
- Patella Dislocation
- knee injection less than 3 months
- Study patient with ACL injury:
- Metallic implants in the proximity of the knee.
- Affections of the Central Nervous System, including Cerebellar dysfunction, Stroke, ALS and MS, affect the strength, motor control and/or coordination of human joints and produce "abnormal" movement patterns;
- Affections of the Peripheral Nervous System of the lower limb, including Lumbar radiculopathy, Peripheral nerve entrapment and Neuropathy, affect the proprioception and muscle force.
- Pregnant women.
- Inflammatory Conditions
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
Nico Buls, PhD, 02 476 3976, Nico.Buls@uzbrussel.be
Petra Dierickx, MSc, 02 474 9774, petra.dierickx@uzbrussel.be
About this study
Official title: Kinematic Assessment of Real-Time Motion Acquisition of the Human Lower Limb Peripheral Joints by Dynamic 4D Transversal Imaging (KARMA-4D)
Aim of the research project:
The entire research project aims to investigate human peripheral joints (knee, foot \& ankle, elbow, wrist \& hand) by dynamic 4D radiographic imaging acquisition during real-time motion.
Read more
Aim of the specific study on Patellofemoral pain syndrome (PFPS) patients:
This study aims to investigate kinematics and motion changes pre and post physiotherapy intervention in patients with patellofemoral pain syndrome (PFPS) and compare them with a healthy control group.
Aim of the specific study on patients undergoing ACL reconstruction:
This study aims to investigate kinematics and motion changes pre and post-surgical intervention in patients with ACL injury that require surgical reconstruction and compare them with a healthy control group.
Read the detailed description
Study on PFPS patients:
Non-randomized Control Clinical Trial. The patient that satisfies inclusion and exclusion criteria is informed about the nature study at the orthopaedic outpatient clinic. If necessary, the study coordinator provides additional information to the patient. Informed consent will be obtained prior to inclusion in the study. The patient will be asked to undergo a dynamic scan of the knees prior to and after the physiotherapy treatment. The physiotherapy treatment is not specifically controlled but best evidence-based guidelines are provided to the patient's physiotherapist in order to have an intervention as homogeneous as possible. Guidelines suggest a tailored and progressive exercise program to improve muscle strength and control, joint mobility, and patient understanding of the problem and how to manage it. Additional interventions like tape or manual treatment can also be implemented but should not be exclusive. During imaging acquisition, the patients lay on the CT's bed with the lower limb inside the gantry. They are asked to perform a repetitive movement of the knee into different planes of motion (i.e. flexion-extension). Before the start of the dynamic CT scan protocol, a physical examination is performed by a physiotherapist. It consists of muscle strength (dynamometer) and joint ROM assessment. VAS scale and Kujala and KOOS questionnaires will be also administrated to the patients. Healthy volunteers will be provided with a brief explanation of the study the moment they make contact to be involved. Further information and informed consent will be obtained on the day of the scan. Identical procedure for the CT scan and physical assessment used with the patient will be used for the healthy subjects.
Study on patients with ACL injury:
Non-randomized Control Clinical Trial. The patient that satisfies inclusion and exclusion criteria is informed about the nature study at the orthopaedic outpatient clinic. If necessary, the study coordinator provides additional information to the patient. Informed consent will be obtained prior to inclusion in the study. The patient will be asked to undergo a dynamic scan of the knees prior to and approximately 6 weeks after ACL surgical reconstruction. Type of surgical intervention is on surgeon discretion following Best-Evidence practice guidelines.
During imaging acquisition, the patients lay on the CT's bed with the lower limb inside the gantry. They are asked to perform a repetitive movement of the knee into different planes of motion (i.e. flexion-extension). Before the start of the dynamic CT scan protocol, a physical examination is performed by a physiotherapist. It consists of muscle strength (dynamometer) and joint ROM assessment. VAS scale and Lysholm and IKDC questionnaires will be also administrated to the patients. Healthy volunteers will be provided with a brief explanation of the study the moment they make contact to be involved. Further information and informed consent will be obtained on the day of the scan. Identical procedure for the CT scan and physical assessment used with the patient will be used for the healthy subjects.
- Conditions
- Patellofemoral Pain Syndrome, ACL Tear
- Being tested
- Physiotherapy or Surgery
- Keywords
- Dynamic CT, Kinematics, Patellofemoral pain syndrome, Rehabilitation, Surgery, ACL reconstruction
- Medical subject headings
- Patellofemoral Pain Syndrome, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy or SurgeryProcedure or surgery
Physiotherapy: Guidelines suggest a tailored and progressive exercise program to improve muscle strength and control, joint mobility, and patient understanding of the problem and how to manage it. Additional interventions like tape or manual treatment can also be implemented but should not be exclusive
Surgery: ACL surgical reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Patient with PFPS or ACL injury | Experimental | Physiotherapy intervention Surgical intervention Receives: Procedure: Physiotherapy or Surgery |
| Healthy control group | No intervention | The healthy control group will not do any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the amount of Rotation of knee joint (degrees)
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Measured: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of the amount of Rotation of knee joint (degrees)
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Measured: Change from Baseline at 6 weeks after surgical intervention
Change of the amount of Translation of knee joint (mm)
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
Measured: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of the amount of Translation of knee joint (mm)
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
Measured: Change from Baseline at 6 weeks after surgical intervention
Secondary outcomes (11)
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
Measured: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
Measured: Change from Baseline at 6 weeks after surgical intervention
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
Measured: Change from Baseline at 6 and 12 months post surgical or physiotherapy intervention
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Measured: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Measured: Change from Baseline at 6 and 12 months post physiotherapy intervention
Change of Kujala or Anterior Knee Pain Scale (AKPS)
13 questions on the Kujala questionnaire total to 100 points.
Measured: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Kujala or Anterior Knee Pain Scale (AKPS)
13 questions on the Kujala questionnaire total to 100 points.
Measured: Change from Baseline at 6 and 12 months post physiotherapy intervention
Change of Lysholm score
The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting
Measured: Change from Baseline at 6 weeks after surgical intervention
Change of Lysholm score
The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting
Measured: Change from Baseline at 6 and 12 months post surgical intervention
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
Measured: Change from Baseline at 6 weeks after surgical intervention
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
Measured: Change from Baseline at 6 and 12 months post surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jun 2020
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
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.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Study on PFPS patients: Non-randomized Controlled clinical trial Study on ACL patients: Non-randomized Controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Johan de Mey, Universitair Ziekenhuis Brussel
- Investigators
- Johan de Mey, Prof, Principal investigator, universitair ZB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732585
- Sponsor's protocol ID
- B.U.N 143201733617
- Acronym
- Karma-4D
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Assessment of Real-Time Motion Acquisition of the Human Lower Limb Peripheral Joints by Dynamic 4D Transversal Imaging (KARMA-4D)
- ClinicalTrials.gov ID
- NCT04732585
- Acronym / sponsor ID
- Karma-4D / B.U.N 143201733617
- Conditions
- Patellofemoral Pain Syndrome, ACL Tear
- Keywords
- Dynamic CT, Kinematics, Patellofemoral pain syndrome, Rehabilitation, Surgery, ACL reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 Feb 2021 (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.
Aim of the research project:
The entire research project aims to investigate human peripheral joints (knee, foot \& ankle, elbow, wrist \& hand) by dynamic 4D radiographic imaging acquisition during real-time motion.
Aim of the specific study on Patellofemoral pain syndrome (PFPS) patients:
This study aims to investigate kinematics and motion changes pre and post physiotherapy intervention in patients with patellofemoral pain syndrome (PFPS) and compare them with a healthy control group.
Aim of the specific study on patients undergoing ACL reconstruction:
This study aims to investigate kinematics and motion changes pre and post-surgical intervention in patients with ACL injury that require surgical reconstruction and compare them with a healthy control group.
Detailed description
Study on PFPS patients:
Non-randomized Control Clinical Trial. The patient that satisfies inclusion and exclusion criteria is informed about the nature study at the orthopaedic outpatient clinic. If necessary, the study coordinator provides additional information to the patient. Informed consent will be obtained prior to inclusion in the study. The patient will be asked to undergo a dynamic scan of the knees prior to and after the physiotherapy treatment. The physiotherapy treatment is not specifically controlled but best evidence-based guidelines are provided to the patient's physiotherapist in order to have an intervention as homogeneous as possible. Guidelines suggest a tailored and progressive exercise program to improve muscle strength and control, joint mobility, and patient understanding of the problem and how to manage it. Additional interventions like tape or manual treatment can also be implemented but should not be exclusive. During imaging acquisition, the patients lay on the CT's bed with the lower limb inside the gantry. They are asked to perform a repetitive movement of the knee into different planes of motion (i.e. flexion-extension). Before the start of the dynamic CT scan protocol, a physical examination is performed by a physiotherapist. It consists of muscle strength (dynamometer) and joint ROM assessment. VAS scale and Kujala and KOOS questionnaires will be also administrated to the patients. Healthy volunteers will be provided with a brief explanation of the study the moment they make contact to be involved. Further information and informed consent will be obtained on the day of the scan. Identical procedure for the CT scan and physical assessment used with the patient will be used for the healthy subjects.
Study on patients with ACL injury:
Non-randomized Control Clinical Trial. The patient that satisfies inclusion and exclusion criteria is informed about the nature study at the orthopaedic outpatient clinic. If necessary, the study coordinator provides additional information to the patient. Informed consent will be obtained prior to inclusion in the study. The patient will be asked to undergo a dynamic scan of the knees prior to and approximately 6 weeks after ACL surgical reconstruction. Type of surgical intervention is on surgeon discretion following Best-Evidence practice guidelines.
During imaging acquisition, the patients lay on the CT's bed with the lower limb inside the gantry. They are asked to perform a repetitive movement of the knee into different planes of motion (i.e. flexion-extension). Before the start of the dynamic CT scan protocol, a physical examination is performed by a physiotherapist. It consists of muscle strength (dynamometer) and joint ROM assessment. VAS scale and Lysholm and IKDC questionnaires will be also administrated to the patients. Healthy volunteers will be provided with a brief explanation of the study the moment they make contact to be involved. Further information and informed consent will be obtained on the day of the scan. Identical procedure for the CT scan and physical assessment used with the patient will be used for the healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study on PFPS patients: Non-randomized Controlled clinical trial Study on ACL patients: Non-randomized Controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patient with PFPS or ACL injury | Experimental | Procedure: Physiotherapy or SurgeryPhysiotherapy intervention Surgical intervention |
| Healthy control group | No intervention | –The healthy control group will not do any intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patellar/anterior knee pain, provoked by functional activities such as Squatting, Ascending/Descending stairs, Prolonged sitting, Kneeling, Jumping and/or running.
- ACL that requires surgical reconstruction. Imaging findings of ACL injury (MRI)
Key exclusion criteria (14 listed)
- Metallic implants in the proximity of the knee.
- Affections of the Central Nervous System, including Cerebellar dysfunction, Stroke, ALS and MS, affect the strength, motor control and/or coordination of human joints and produce "abnormal" movement patterns;
- Affections of the Peripheral Nervous System of the lower limb, including Lumbar radiculopathy, Peripheral nerve entrapment and Neuropathy, affect the proprioception and muscle force.
- Pregnant women.
- Inflammatory Conditions
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 |
|---|---|---|
| Physiotherapy or SurgeryPhysiotherapy: Guidelines suggest a tailored and progressive exercise program to improve muscle strength and control, joint mobility, and patient understanding of the problem and how to manage it. Additional interventions like tape or manual treatment can also be implemented but should not be exclusive Surgery: ACL surgical reconstruction | Procedure or surgery | Patient with PFPS or ACL injury |
Primary outcome
Change of the amount of Rotation of knee joint (degrees)
Time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Change of the amount of Rotation of knee joint (degrees)
Time frame: Change from Baseline at 6 weeks after surgical intervention
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Change of the amount of Translation of knee joint (mm)
Time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
Change of the amount of Translation of knee joint (mm)
Time frame: Change from Baseline at 6 weeks after surgical intervention
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
11 secondary outcomes
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Time frame: Change from Baseline at 6 weeks after surgical intervention
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Time frame: Change from Baseline at 6 and 12 months post surgical or physiotherapy intervention
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from Baseline at 6 and 12 months post physiotherapy intervention
Change of Kujala or Anterior Knee Pain Scale (AKPS)
Time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Change of Kujala or Anterior Knee Pain Scale (AKPS)
Time frame: Change from Baseline at 6 and 12 months post physiotherapy intervention
Change of Lysholm score
Time frame: Change from Baseline at 6 weeks after surgical intervention
Change of Lysholm score
Time frame: Change from Baseline at 6 and 12 months post surgical intervention
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: Change from Baseline at 6 weeks after surgical intervention
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: Change from Baseline at 6 and 12 months post surgical intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
RecruitingObservational study
Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms
Knee Osteoarthritis, Patellofemoral Pain (PFPS)
RecruitingPhase 3
Comparing the Outcome of Electrical Stimulation and Physical Therapy in Patellofemoral Pain Syndrome
Patellofemoral Pain Syndrome
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.
Johan de Mey, Prof principal investigator
universitair ZB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy or Surgery in people with Patellofemoral Pain Syndrome and ACL Tear, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra Dierickx, SC (+32 (0)2 474 9774, petra.dierickx@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the amount of Rotation of knee joint (degrees) (time frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention). The study lists 4 primary outcomes in all. 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 1 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.