- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01890551
Kine-Mri in Patellofemoral Instability (Knee- MRI 2012)
June 27, 2013 updated by: Matti Eskelinen, Kuopio University Hospital
Dynamic Kine-mri in Patellofemoral Instability in Adolescents- an Aid in the Diagnosis
Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with unilateral patellofemoral instability.
For the control group invvestigators enrolled ten healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and the HKG subjects (n=19).
Results: In a comparison between the AKG patients and the HKG subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test.
In these parameters the difference between the AKG patients and the HKG subjects progressively increased towards the full extension of the knee.
In the AKG and UAKG patients BSO-ratio at 0 degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG subjects ranged between 0.33 and 0.75 (P < .001).
At the zero degree the LPD-test ranged between 0 and 10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients, whereas the lateral displacement-test ranged between 0 and 5 mm in the HKG subjects (P = .003).
Patellar tilt angle-test ranged between -30 and 20 degrees in the AKG patients and between -30 and 24 degrees in the UAKG patients and in the HKG subjects the PTA-test ranged between 10 and 24 degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for the evaluation of patellar tracking in adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Purpose: The impact of kinematic-MRI (KINE-MRI) in the patellofemoral instability and anterior knee pain of the adolescents is rarely reported.Interest was to evaluate the patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected knees in a case-control study.Methods: KINE-MRI was performed in 29 adolescents (affected knee group, AKG, n=29 and n=26 unaffected knee group, UAKG, n=26) aged 11-16 years with unilateral patellofemoral instability.
For the control group investigators enrolled ten healthy age- and sex-matched volunteers (healthy knee group, HKG, n=19 ).The study parameters, Bisect Offset (BSO), Lateral Patellar Displacement (LPD), Patellar Tilt Angle (PTA), Sulcus Angle and Insall-Salvati ratio at 0, 10, 20 and 30 degrees of flexion-extension, were measured for the AKG patients (n=29), and UAKG patients (n=26) and the HKG subjects (n=19).
Results: In a comparison between the AKG patients and the HKG subjects there was a significant difference in the BSO-ratio, LPD-test and PTA-test.
In these parameters the difference between the AKG patients and the HKG subjects progressively increased towards the full extension of the knee.
In the AKG and UAKG patients BSO-ratio at 0 degree ranged between 0.5 and 1.2 in both groups, whereas the BSO-ratio in the HKG subjects ranged between 0.33 and 0.75 (P < .001).
At the zero degree the LPD-test ranged between 0 and 10 mm in the AKG patients and between 0 and 35 mm in the UAKG patients, whereas the lateral displacement-test ranged between 0 and 5 mm in the HKG subjects (P = .003).
Patellar tilt angle-test ranged between -30 and 20 degrees in the AKG patients and between -30 and 24 degrees in the UAKG patients and in the HKG subjects the PTA-test ranged between 10 and 24 degrees (P < .001).Conclusion: The KINE-MRI could be a feasible method for the evaluation of patellar tracking in adolescents.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northern Savo
-
Kuopio, Northern Savo, Finland, 70029
- Kuopio University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The inclusion criteria for the 29 patients were as follows: objective patellar instability with or without objective or episodic patellar dislocation, anterior knee pain for more than one year with positive apprehension tests, J-tracking of the patella, lateral tilt and displacement proven clinically.
Exclusion Criteria:
- did not enroll any patients with the knee trauma, the previous surgery and the osteochondritic lesions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: affected knee
Interest was to evaluate the patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected knees in a case-control study
|
Dynamic kinematic (KINE) magnetic resonance imaging (MRI) of the patellofemoral joint.
|
|
Other: unaffected knee
Interest was to evaluate the patellofemoral joint biomechanics with KINE-MRI in adolescents with affected and unaffected knees in a case-control study
|
Dynamic kinematic (KINE) magnetic resonance imaging (MRI) of the patellofemoral joint.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bisect Offset (BSO)
Time Frame: One year
|
BSO is the ratio of medial to lateral displacement of the patella (Brossmann et al.
Radiology 1993).
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral Patellar Displacement (LPD)
Time Frame: One year
|
LPD is the lateral displacement of the patella.
|
One year
|
|
Patellar Tilt Angle (PTA)
Time Frame: One year
|
PTA measures the lateral tilting of the patella.
|
One year
|
|
Sulcus Angle
Time Frame: One year
|
Sulcus Angle measures the angle formed by the medial and lateral borders of the trochlea
|
One year
|
|
Insall-Salvati-ratio
Time Frame: One year
|
Insall-Salvati-ratio measures the ratio of the length of the patella to the length of the patellar ligament.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matti Eskelinen, professor, Kuopio University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1998
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
June 18, 2013
First Submitted That Met QC Criteria
June 27, 2013
First Posted (Estimate)
July 1, 2013
Study Record Updates
Last Update Posted (Estimate)
July 1, 2013
Last Update Submitted That Met QC Criteria
June 27, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- KUH5203078
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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