Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

NCT ID: NCT04838158

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-10

Study Completion Date

2016-01-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Patella Dislocation Recurrent Children, Only

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention group

Those cases who underwent operative treatment and isokinetics evaluation.

Group Type ACTIVE_COMPARATOR

Isokinetic measurements

Intervention Type DIAGNOSTIC_TEST

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).

Control group

Those who were control group of healthy subjects to compare to normative data

Group Type OTHER

Isokinetic measurements

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krzysztof Małecki, Ph.D.

Role: STUDY_DIRECTOR

Polish Mother's Memorial Hospital Research Institute

Jarosław Fabiś, prof.

Role: STUDY_CHAIR

Medical University of Lodz

Paweł Flont, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Polish Mother's Memorial Hospital Research Institute

Anna Fabiś-Strobin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Polish Mother's Memorial Hospital Research Institute

Kryspin Niedzielski, prof.

Role: STUDY_CHAIR

Polish Mother's Memorial Hospital Research Institute

References

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Malecki K, Fabis J, Flont P, Fabis-Strobin A, Niedzielski K. Assessment of knee flexor muscles strength in patients with patellar instability and its clinical implications for the non-surgical treatment of patients after first patellar dislocation - pilot study. BMC Musculoskelet Disord. 2021 Aug 28;22(1):740. doi: 10.1186/s12891-021-04636-4.

Reference Type DERIVED
PMID: 34454460 (View on PubMed)

Other Identifiers

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PolishMMHRI 23/06/2010

Identifier Type: -

Identifier Source: org_study_id

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