Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study

Medial Patellofemoral Dislocation Clinical Trial

— MPFL  

Official title:

Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257836
• Other study ID #: Danish EC: 1-10-72-299-21
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: Torsten G Nielsen, MHSc
• Phone: +4540491184
• Email: torsne[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this project is to investigate the treatment outcome after MPFL reconstruction in children as a treatment for chronic patellar instability, where the superficial part of the quadriceps tendon is fixed to the femur with anchors.

The outcome will be compared with a healthy cohort matched on age and gender.

Description:

Lateral patella dislocation (PL) is defined as a total dislocation of the patella out of the trochlea.

In chronic patella instability, where the patella has been repeatedly dislocated, the treatment is most often surgical. The main ligamentous structure that stabilizes the patella against lateralization is the medial patello-femoral ligament (MPFL). The MPFL is a centimeter-thin ligamentous structure that runs from the upper medial patellar border to the medial femoral epicondyle. This ligament is torn in more than 90% of cases of PL and healing of the ligament is often insufficient, especially if there are predisposing factors in the knee joint such as dysplasia of the patello-femoral joint, high standing patella (patella alta) and hypermobility.

MPFL reconstruction (MPFL-r) can be performed with many different surgical techniques, but the basic principle is to use autologous tendon tissue to create a new MPFL by anchoring the new tendon tissue to the medial patellar border and the medial femoral epicondyle, while ensuring isometry of the reconstruction.

A number of different methods have been described for anchoring the new MPFL to the patella and femoral condyle.

The most commonly used type of graft for MPFL-r is the gracilis tendon, which is fixed with screws in the femur bone preceded by drilling a channel in the femoral condyle.

In non-grown patients, the growth zone of the distal femur is very close to the anatomical attachment of the MPFL. This poses a problem as a reaming that hits the growth zone carries a theoretical risk of compromising growth around the knee.

In addition, up to 50% of patients describe pain at 1 year after surgery if screw fixation is used in the medial femoral condyle.

A new MPFL-r method using a superficial portion of the quadriceps tendon fixed with an anchor provides a good 2-year result compared to gracilis tendon and screw fixation.

The effectiveness and long-term efficacy of MPFL surgery with the quadriceps tendon for children is not well described in the literature.

At the Department of Sports Traumatology in Aarhus, Denmark, the quadriceps technique has been used on non-adult patients since 2016.

In this study, the investigators want to include the 80 patients who have undergone this MPFL-r since 2016 with the quadriceps tendon technique and have a minimum of 2 years of follow-up. This patient group will compared to a healthy cohort matched on age and gender.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 23 Years

Eligibility

Inclusion Criteria - Intervention group:

• MPFL-reconstruction with Quadriceps tendon graft

• Open physis at surgery date

• Minimum 2 years Follow up

Exclusion Criteria - Intervention group:

• More surgeries in index knee

• MPFL-r in opposite knee

• MPFL revision in index knee

Inclusion Criteria - Healthy group:

• No knee problems

Exclusion Criteria - Healthy group

• None

• No knee problems

Related Conditions & MeSH terms

• Medial Patellofemoral Ligament Reconstruction

Intervention

Other:
• MPFL-reconstruction
Children with patella dislocations are operated from 2016-2022 with a quadriceps knee cap stabilization technique.

Locations

Country	Name	City	State
Denmark	Division of Sports Trauma, Palle Juul-Jensens Boulevard 99	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kujala (Anterior Knee Pain Scale)	Patient reported outcome score, 0=worst and 100=best	24 month
Secondary	Donor site morbidity score, 0=worst and 100=best	Patient reported outcome score	24 month
Secondary	Numerical Rating Scale (NRS-pain score)	Patient reported outcome score, 0=Best and 10=worst	24 month
Secondary	Tegner (Activity Score)	Patient reported outcome score, 0=worst and 10=best	24 month
Secondary	Knee pain	Palpatory pain in relation to graft fixation in femur on a four-point likert scale (0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain)	24 month
Secondary	One-legged single hop for distance	Physical performance test	24 month
Secondary	One-legged triple hop for distance	Physical performance test	24 month
Secondary	Side-to-side hop test	Physical performance test	24 month
Secondary	Quadriceps Strength test	Physical performance test. Hand held dynamometry	24 month
Secondary	Gluteus Medius Strength test	Physical performance test. Hand held dynamometry	24 month