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CompletedNCT03983213Updated Feb 12, 2021

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

An observational study in Recurrent Patellar Dislocation and Patellar Instability, sponsored by Polish Mother Memorial Hospital Research Institute. Completed at 1 site in Poland. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.

Sponsored by Polish Mother Memorial Hospital Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
31
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Recurrent Patellar Dislocation
  • Patellar Instability

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Keywords

  • Patellar instability
  • Recurrent patellar dislocation
  • Isokinetics
  • Children
  • MPFL reconstruction
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's enrollment of 31 is below the median of 100 across 15 observational studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Polish Mother Memorial Hospital Research Institute is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age \<18 yo
  • osteochondral fracture
  • habitual dislocation
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • Pat. after mpfl reconstruction

    All 45 subjects operated with mpfl reconstruction included to chek-up after follow-up.

    Procedure: mpfl reconstruction

Interventions

  • Procedurempfl reconstruction

    Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.

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What researchers measure

Primary outcomes

  1. Dislocation recurrence

    The incident of patellar dislocation after treatment

    Time frame: 2 years

07

Study locations

1 site
  • Polish Mother Memorial Hospital Research Institute
    Łódź, 93-338, Poland
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References and documents

Individual participant data

Plan to share: Yes — Sharing IPD after data collection in Exel

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: After data collection

Access criteria: Not known yet

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03983213
Lead sponsor
Polish Mother Memorial Hospital Research Institute
Responsible party
Sponsor
First posted
Jun 12, 2019
Start date
May 28, 2019
Primary completion
Oct 30, 2020
Completion
Nov 30, 2020
Last update
Feb 12, 2021

Study contacts

Kryspin Niedzielski, Ph.D.
study chair · Polish Mother Memorial Hospital Research Institute
Krzysztof Małecki, Ph.D.
study director · Polish Mother Memorial Hospital Research Institute
Jacek Beczkowski, M.D.
principal investigator · Polish Mother Memorial Hospital Research Institute
Paweł Flont, Ph. D.
principal investigator · Polish Mother Memorial Hospital Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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