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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Finland
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Dynamic kine-mri
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
Other: Dynamic kine-mri
Dynamic kinematic (KINE) magnetic resonance imaging (MRI) of the patellofemoral joint.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kuopio University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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