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Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

Primary Purpose

Patella Dislocation Recurrent, Children, Only

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isokinetic measurements
Sponsored by
Polish Mother Memorial Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patella Dislocation Recurrent

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Intervention group

    Control group

    Arm Description

    Those cases who underwent operative treatment and isokinetics evaluation.

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

    Outcomes

    Primary Outcome Measures

    hamstrings peak torque
    measured on Biodex System
    torque in 30 degrees of the knee flexion
    measured on Biodex System
    angle of peak torque
    measured on Biodex System
    peak torque hamstring to quadriceps ratio (H/Q ratio)
    measured on Biodex System

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2021
    Last Updated
    April 6, 2021
    Sponsor
    Polish Mother Memorial Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04838158
    Brief Title
    Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability
    Official Title
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2015 (Actual)
    Primary Completion Date
    January 30, 2016 (Actual)
    Study Completion Date
    January 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Polish Mother Memorial Hospital Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patella Dislocation Recurrent, Children, Only

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Active Comparator
    Arm Description
    Those cases who underwent operative treatment and isokinetics evaluation.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Those who were control group of healthy subjects to compare to normative data
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Isokinetic measurements
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    hamstrings peak torque
    Description
    measured on Biodex System
    Time Frame
    up to 18 months
    Title
    torque in 30 degrees of the knee flexion
    Description
    measured on Biodex System
    Time Frame
    up to 18 months
    Title
    angle of peak torque
    Description
    measured on Biodex System
    Time Frame
    up to 18 months
    Title
    peak torque hamstring to quadriceps ratio (H/Q ratio)
    Description
    measured on Biodex System
    Time Frame
    up to 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Krzysztof Małecki, Ph.D.
    Organizational Affiliation
    Polish Mother's Memorial Hospital Research Institute
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jarosław Fabiś, prof.
    Organizational Affiliation
    Medical University of Lodz
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Paweł Flont, Ph.D.
    Organizational Affiliation
    Polish Mother's Memorial Hospital Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anna Fabiś-Strobin, Ph.D.
    Organizational Affiliation
    Polish Mother's Memorial Hospital Research Institute
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kryspin Niedzielski, prof.
    Organizational Affiliation
    Polish Mother's Memorial Hospital Research Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    34454460
    Citation
    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.
    Results Reference
    derived

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    Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

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