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
About this trial
This is an interventional diagnostic trial for Patella Dislocation Recurrent
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
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
NCT ID
NCT04838158
First Posted
March 22, 2021
Last Updated
April 6, 2021
Sponsor
Polish Mother Memorial Hospital Research Institute
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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