Clinical trial NCT03983213: The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.
Official title: The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Patellar Dislocation
Patellar Instability
Keywords: Patellar instability
Recurrent patellar dislocation
Isokinetics
Children
MPFL reconstruction
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 patients under 18 yo, 30 females, 15 males, average age of 15 yo

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* age \<18 yo
* osteochondral fracture
* habitual dislocation

Primary outcomes:
measure: Dislocation recurrence
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Polish Mother Memorial Hospital Research Institute
Study officials:
affiliation: Polish Mother Memorial Hospital Research Institute
name: Kryspin Niedzielski, Ph.D.
role: STUDY_CHAIR
affiliation: Polish Mother Memorial Hospital Research Institute
name: Krzysztof Małecki, Ph.D.
role: STUDY_DIRECTOR
affiliation: Polish Mother Memorial Hospital Research Institute
name: Jacek Beczkowski, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Polish Mother Memorial Hospital Research Institute
name: Paweł Flont, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: