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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04838158
Other study ID # PolishMMHRI 23/06/2010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2015
Est. completion date January 30, 2016

Study information

Verified date January 2021
Source Polish Mother Memorial Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. In the study group, both side hamstring muscle were evaluated at the velocities of 60 and 180 deg/s for the following parameters: peak torque, torque in 30 degree of the knee flexion, angle of peak torque and peak torque hamstring to quadriceps ratio (H/Q ratio).


Description:

The study enrolled 33 patients with confirmed recurrent patellar dislocation, including 6 patients with bilateral involvement. The study group consisted of 20 girls and 13 boys with average age at the time of the study 16.2 years (range: 8 to 17 years, SD 2.7). For the purpose of the study, a control group of 18 healthy subjects (12 girls and 6 boys) aged on the average 15.7 years (range:13 to 17 years, SD 1.5), was recruited. The following study inclusion criteria were applied: recurrent patellar dislocation, correctly completed testing protocol, age under 18 years at the time of testing. Subjects with osteochondral fracture and those with a history of the knee surgery were excluded. Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio). Isokinetic measurements were made by a trained, experienced physiotherapist. After a proper warm-up and instruction, the test performed 10 full repetitions, the best result was recorded. The results of the peak torque (PT) of both test and control limbs were then compared with the normative data for age and gender available in the literature. In addition, we compared the peak torque (PT), torque in 30 degrees of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio) of involved and uninvolved knee flexor strength in the study group. Depending on the data distribution, the nonparametric Wilcoxon's test or the parametric t-test for the related data was applied. Statistical significance was assumed for p<0.05. The study was approved by our Institutional Review Board. Informed consent was obtained and the rights of subjects were protected.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 30, 2016
Est. primary completion date January 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - recurrent patellar dislocation, - correctly completed testing protocol, - age under 18 years at the time of testing Exclusion Criteria: - osteochondral fracture - those with a history of the knee surgery

Study Design


Intervention

Diagnostic Test:
Isokinetic measurements
Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Polish Mother Memorial Hospital Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary hamstrings peak torque measured on Biodex System up to 18 months
Primary torque in 30 degrees of the knee flexion measured on Biodex System up to 18 months
Primary angle of peak torque measured on Biodex System up to 18 months
Primary peak torque hamstring to quadriceps ratio (H/Q ratio) measured on Biodex System up to 18 months
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