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

Patellar Instability Clinical Trial

Official title:

The Clinical, Radiological, Isokinetic Assessment With Gait Analysis in Children After Surgical Treatment of Patellar Recurrent Dislocation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03983213
• Other study ID #: PMMHRI-BCO.34/2019
• Status: Completed
• Start date: May 28, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• age <18 yo

• recurrent patellar dislocation

• ready for follow-up

Exclusion Criteria:

• age <18 yo

• osteochondral fracture

• habitual dislocation

Related Conditions & MeSH terms

• Patellar Dislocation
• Patellar Instability
• Recurrent Patellar Dislocation

Intervention

Procedure:
• mpfl reconstruction
Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.

Locations

Country	Name	City	State
Poland	Polish Mother Memorial Hospital Research Institute	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dislocation recurrence	The incident of patellar dislocation after treatment	2 years