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

NCT ID: NCT03983213

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Patellar Dislocation Patellar Instability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pat. after mpfl reconstruction

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

mpfl reconstruction

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mpfl reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* age \<18 yo
* osteochondral fracture
* habitual dislocation
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kryspin Niedzielski, Ph.D.

Role: STUDY_CHAIR

Polish Mother Memorial Hospital Research Institute

Krzysztof Małecki, Ph.D.

Role: STUDY_DIRECTOR

Polish Mother Memorial Hospital Research Institute

Jacek Beczkowski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Polish Mother Memorial Hospital Research Institute

Paweł Flont, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Polish Mother Memorial Hospital Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Polish Mother Memorial Hospital Research Institute

Lodz, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMMHRI-BCO.34/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric and Adolescent Patellar Instability
NCT02333825 ENROLLING_BY_INVITATION NA
Validation of Kujala German
NCT01495507 UNKNOWN