Assessment of Knee Flexor Muscles Strength in Patients With Patellar Instability

NCT04838158 | Completed

• 1 other identifier: PolishMMHRI 23/06/2010
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Patella Dislocation Recurrent; Children, Only

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Those cases who underwent operative treatment and isokinetics evaluation.

Diagnostic Test: Isokinetic measurements

Control group

OTHER

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

Diagnostic Test: Isokinetic measurements

Interventions

Isokinetic measurements 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; Intervention group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• recurrent patellar dislocation,
• correctly completed testing protocol,
• age under 18 years at the time of testing

You may not qualify if:

• osteochondral fracture
• those with a history of the knee surgery

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Related Publications (1)

• 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.

  PMID: 34454460 DERIVED

Study Officials

• Krzysztof Małecki, Ph.D.

  Polish Mother's Memorial Hospital Research Institute

  STUDY DIRECTOR

• Jarosław Fabiś, prof.

  Medical University of Lodz

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Kryspin Niedzielski, prof.

  Polish Mother's Memorial Hospital Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 8, 2021
• Study Start: January 10, 2015
• Primary Completion: January 30, 2016
• Study Completion: January 30, 2016
• Last Updated: April 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: April 2021 - December 2023
• Access Criteria: Upon reasonable request on e-mail krzynormal@wp.pl