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

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ClinicalTrials.gov Identifier: NCT03983213
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Polish Mother Memorial Hospital Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Recurrent Patellar Dislocation Patellar Instability 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.

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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Dislocation recurrence [ Time Frame: 2 years ]
    The incident of patellar dislocation after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
45 patients under 18 yo, 30 females, 15 males, average age of 15 yo
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age <18 yo
  • osteochondral fracture
  • habitual dislocation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983213


Locations
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Poland
Polish Mother Memorial Hospital Research Institute
Łódź, Poland, 93-338
Sponsors and Collaborators
Polish Mother Memorial Hospital Research Institute
Investigators
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Study Chair: Kryspin Niedzielski, Ph.D. Polish Mother Memorial Hospital Research Institute
Study Director: Krzysztof Małecki, 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
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Responsible Party: Polish Mother Memorial Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03983213    
Other Study ID Numbers: PMMHRI-BCO.34/2019
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing IPD after data collection in Exel
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After data collection
Access Criteria: Not known yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Polish Mother Memorial Hospital Research Institute:
Patellar instability
Recurrent patellar dislocation
Isokinetics
Children
MPFL reconstruction
Additional relevant MeSH terms:
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Joint Dislocations
Patellar Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Knee Injuries
Leg Injuries