The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.

The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.

The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction. Follow-up longer than 2 years in all cases, about 45 patients included.

Study Overview

• Status: Completed
• Conditions: Recurrent Patellar Dislocation; Patellar Instability
• Intervention / Treatment: Procedure: mpfl reconstruction

Detailed Description

Recurrent patellar dislocation occurs mostly in adolescents. Recently medial patellofemoral ligament reconstruction has become treatment of choice in most cases. There is still insufficient literature to assess the operative treatment results according to functional testing.

The aim of this prospective study is to assess extension apparatus function of the knee based on clinical, radiological, isokinetic and gait analysis data in patients after surgical treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar position verification along with isokinetic and gait evaluation to produce conclusions referring to efficacy of the treatment. All subjects included in the study were treated with mpfl reconstruction with gracilis tendon harvesting. Follow-up provided is longer than 2 years in all 45 cases planned to enroll. All subject are to be mailed and invited to check-up visit including analysis of parameters mentioned above. Soon after data collection text of the publication will be made. The results will be discussed with recent literature and conclusions will be made.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 93-338
    • Polish Mother Memorial Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

45 patients under 18 yo, 30 females, 15 males, average age of 15 yo

Description

Inclusion Criteria:

• age <18 yo
• recurrent patellar dislocation
• ready for follow-up

Exclusion Criteria:

• age <18 yo
• osteochondral fracture
• habitual dislocation

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pat. after mpfl reconstruction; All 45 subjects operated with mpfl reconstruction included to chek-up after follow-up.	Procedure: mpfl reconstruction; Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation recurrence	The incident of patellar dislocation after treatment	2 years

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute
• Investigators: Study Chair: Kryspin Niedzielski, Ph.D., Polish Mother Memorial Hospital Research Institute; Principal Investigator: Jacek Beczkowski, M.D., Polish Mother Memorial Hospital Research Institute; Principal Investigator: Paweł Flont, Ph. D., Polish Mother Memorial Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Children; Patellar instability; Isokinetics; MPFL reconstruction; Recurrent patellar dislocation
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Knee Injuries; Recurrence; Joint Dislocations; Patellar Dislocation
• Other Study ID Numbers: PMMHRI-BCO.34/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing IPD after data collection in Exel
• IPD Sharing Time Frame: After data collection
• IPD Sharing Access Criteria: Not known yet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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