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.
1 other identifier
observational
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2019
CompletedFirst Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedFebruary 12, 2021
September 1, 2020
1.4 years
June 10, 2019
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dislocation recurrence
The incident of patellar dislocation after treatment
2 years
Study Arms (1)
Pat. after mpfl reconstruction
All 45 subjects operated with mpfl reconstruction included to chek-up after follow-up.
Interventions
Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.
Eligibility Criteria
45 patients under 18 yo, 30 females, 15 males, average age of 15 yo
You may qualify if:
- age \<18 yo
- recurrent patellar dislocation
- ready for follow-up
You may not qualify if:
- age \<18 yo
- osteochondral fracture
- habitual dislocation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Polish Mother Memorial Hospital Research Institute
Lodz, 93-338, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2019
First Posted
June 12, 2019
Study Start
May 28, 2019
Primary Completion
October 30, 2020
Study Completion
November 30, 2020
Last Updated
February 12, 2021
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After data collection
- Access Criteria
- Not known yet
Sharing IPD after data collection in Exel