Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability and Its Clinical Implication in Non-surgical Treatment of Patients After First Patella Dislocation.

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).

Study Overview

• Status: Completed
• Conditions: Children, Only; Patella Dislocation Recurrent
• Intervention / Treatment: Diagnostic test: Isokinetic measurements

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group; Those cases who underwent operative treatment and isokinetics evaluation.	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).
OTHER: Control group; Those who were control group of healthy subjects to compare to normative data	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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute
• Investigators: Study Director: Krzysztof Małecki, Ph.D., Polish Mother's Memorial Hospital Research Institute; Study Chair: Jarosław Fabiś, prof., Medical University of Lodz; Principal Investigator: Paweł Flont, Ph.D., Polish Mother's Memorial Hospital Research Institute; Principal Investigator: Anna Fabiś-Strobin, Ph.D., Polish Mother's Memorial Hospital Research Institute; Study Chair: Kryspin Niedzielski, prof., Polish Mother's Memorial Hospital Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2015
• Primary Completion (ACTUAL): January 30, 2016
• Study Completion (ACTUAL): January 30, 2016

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: PolishMMHRI 23/06/2010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Research protocol, personal results, informed consent
• IPD Sharing Time Frame: April 2021 - December 2023
• IPD Sharing Access Criteria: Upon reasonable request on e-mail krzynormal@wp.pl
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No