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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01890551
Other study ID # KUH5203078
Secondary ID
Status Completed
Phase N/A
First received June 18, 2013
Last updated June 27, 2013
Start date January 1998
Est. completion date January 2013

Study information

Verified date June 2013
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Valvira - National Supervisory Authority for Welfare and HealthFinland: National Advisory Board on Health Care Ethics
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 16 Years
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms

  • Affected and Unaffected Knee in Adoloescent

Intervention

Other:
Dynamic kine-mri
Dynamic kinematic (KINE) magnetic resonance imaging (MRI) of the patellofemoral joint.

Locations

Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (1)

Lead Sponsor Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bisect Offset (BSO) BSO is the ratio of medial to lateral displacement of the patella (Brossmann et al. Radiology 1993). One year No
Secondary Lateral Patellar Displacement (LPD) LPD is the lateral displacement of the patella. One year No
Secondary Patellar Tilt Angle (PTA) PTA measures the lateral tilting of the patella. One year No
Secondary Sulcus Angle Sulcus Angle measures the angle formed by the medial and lateral borders of the trochlea One year No
Secondary Insall-Salvati-ratio Insall-Salvati-ratio measures the ratio of the length of the patella to the length of the patellar ligament. One year No