- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732585
Kinematic Assessment of Human Peripheral Joints by Dynamic CT (Karma-4D)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Petra Dierickx, SC
- Phone Number: +32 (0)2 474 9774
- Email: petra.dierickx@uzbrussel.be
Study Contact Backup
- Name: Nico Buls, Prof
- Phone Number: +32 (0)2 476 3976
- Email: nico.buls@uzbrussel.be
Study Locations
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-
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Brussel, Belgium, 1090
- Recruiting
- UZ Brussel
-
Contact:
- Nico Buls, PhD
- Phone Number: 02 476 3976
- Email: Nico.Buls@uzbrussel.be
-
Contact:
- Petra Dierickx, MSc
- Phone Number: 02 474 9774
- Email: petra.dierickx@uzbrussel.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study patient with PFPS:
Inclusion Criteria:
patellar/anterior knee pain, provoked by functional activities such as Squatting, Ascending/Descending stairs, Prolonged sitting, Kneeling, Jumping and/or running.
Exclusion Criteria:
- 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
- Patella Dislocation
- knee injection less than 3 months
Study patient with ACL injury:
Inclusion Criteria:
ACL that requires surgical reconstruction. Imaging findings of ACL injury (MRI)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Patient with PFPS or ACL injury
Physiotherapy intervention Surgical intervention
|
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 |
NO_INTERVENTION: Healthy control group
The healthy control group will not do any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 from Baseline at 1-3 weeks after the end of physiotherapy intervention
|
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 from Baseline at 6 weeks after surgical intervention
|
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 from Baseline at 1-3 weeks after the end of physiotherapy intervention
|
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
|
Change from Baseline at 6 weeks after surgical intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Patient choose between 0-10 integers that best reflects the intensity of the pain
|
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
|
Patient choose between 0-10 integers that best reflects the intensity of the pain
|
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
|
Patient choose between 0-10 integers that best reflects the intensity of the pain
|
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
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It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
|
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
|
It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
|
Change from Baseline at 6 and 12 months post physiotherapy intervention
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Change of Kujala or Anterior Knee Pain Scale (AKPS)
Time Frame: Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
|
13 questions on the Kujala questionnaire total to 100 points.
|
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
|
13 questions on the Kujala questionnaire total to 100 points.
|
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
|
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
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Change from Baseline at 6 weeks after surgical intervention
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Change of Lysholm score
Time Frame: Change from Baseline at 6 and 12 months post surgical intervention
|
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
|
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
|
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
|
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
|
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
|
Change from Baseline at 6 and 12 months post surgical intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan de Mey, Prof, universitair ZB
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.U.N 143201733617
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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