Kinematic Assessment of Human Peripheral Joints by Dynamic CT (Karma-4D)
Primary Purpose
Patellofemoral Pain Syndrome, ACL Tear
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Physiotherapy or Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Dynamic CT, Kinematics, Patellofemoral pain syndrome, Rehabilitation, Surgery, ACL reconstruction
Eligibility Criteria
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
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient with PFPS or ACL injury
Healthy control group
Arm Description
Physiotherapy intervention Surgical intervention
The healthy control group will not do any intervention
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Patient choose between 0-10 integers that best reflects the intensity of the pain
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.
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.
Change of Kujala or Anterior Knee Pain Scale (AKPS)
13 questions on the Kujala questionnaire total to 100 points.
Change of Kujala or Anterior Knee Pain Scale (AKPS)
13 questions on the Kujala questionnaire total to 100 points.
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
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
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)
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)
Full Information
NCT ID
NCT04732585
First Posted
January 21, 2021
Last Updated
January 26, 2021
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04732585
Brief Title
Kinematic Assessment of Human Peripheral Joints by Dynamic CT
Acronym
Karma-4D
Official Title
Kinematic Assessment of Real-Time Motion Acquisition of the Human Lower Limb Peripheral Joints by Dynamic 4D Transversal Imaging (KARMA-4D)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, ACL Tear
Keywords
Dynamic CT, Kinematics, Patellofemoral pain syndrome, Rehabilitation, Surgery, ACL reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study on PFPS patients:
Non-randomized Controlled clinical trial
Study on ACL patients:
Non-randomized Controlled clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with PFPS or ACL injury
Arm Type
Experimental
Arm Description
Physiotherapy intervention Surgical intervention
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
The healthy control group will not do any intervention
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy or Surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of the amount of Rotation of knee joint (degrees)
Description
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Time Frame
Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Title
Change of the amount of Rotation of knee joint (degrees)
Description
Rotations calculated as Cardan angles, rotation around the axis of rotation, Lateral Tilt of the Patella
Time Frame
Change from Baseline at 6 weeks after surgical intervention
Title
Change of the amount of Translation of knee joint (mm)
Description
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
Time Frame
Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Title
Change of the amount of Translation of knee joint (mm)
Description
Translation of individual bones, translation of the axis of rotation and tibial-tuberosity to trochlear groove distance
Time Frame
Change from Baseline at 6 weeks after surgical intervention
Secondary Outcome Measure Information:
Title
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Description
Patient choose between 0-10 integers that best reflects the intensity of the pain
Time Frame
Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Title
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Description
Patient choose between 0-10 integers that best reflects the intensity of the pain
Time Frame
Change from Baseline at 6 weeks after surgical intervention
Title
Change of Pain assessed by Numeric Pain Rating scale (NPRS)
Description
Patient choose between 0-10 integers that best reflects the intensity of the pain
Time Frame
Change from Baseline at 6 and 12 months post surgical or physiotherapy intervention
Title
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Time Frame
Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Title
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
It is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Time Frame
Change from Baseline at 6 and 12 months post physiotherapy intervention
Title
Change of Kujala or Anterior Knee Pain Scale (AKPS)
Description
13 questions on the Kujala questionnaire total to 100 points.
Time Frame
Change from Baseline at 1-3 weeks after the end of physiotherapy intervention
Title
Change of Kujala or Anterior Knee Pain Scale (AKPS)
Description
13 questions on the Kujala questionnaire total to 100 points.
Time Frame
Change from Baseline at 6 and 12 months post physiotherapy intervention
Title
Change of Lysholm score
Description
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
Time Frame
Change from Baseline at 6 weeks after surgical intervention
Title
Change of Lysholm score
Description
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
Time Frame
Change from Baseline at 6 and 12 months post surgical intervention
Title
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
Time Frame
Change from Baseline at 6 weeks after surgical intervention
Title
Change of International Knee Documentation Committee Subjective Knee Form (IKDC)
Description
The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items)
Time Frame
Change from Baseline at 6 and 12 months post surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra Dierickx, SC
Phone
+32 (0)2 474 9774
Email
petra.dierickx@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Nico Buls, Prof
Phone
+32 (0)2 476 3976
Email
nico.buls@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan de Mey, Prof
Organizational Affiliation
universitair ZB
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nico Buls, PhD
Phone
02 476 3976
Email
Nico.Buls@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Petra Dierickx, MSc
Phone
02 474 9774
Email
petra.dierickx@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
No
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Kinematic Assessment of Human Peripheral Joints by Dynamic CT
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