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Clinical Trials/NCT06257836
NCT06257836
Active, Not Recruiting
N/A

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

Aarhus University Hospital1 site in 1 country160 target enrollmentMarch 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medial Patellofemoral Dislocation
Sponsor
Aarhus University Hospital
Enrollment
160
Locations
1
Primary Endpoint
Kujala (Anterior Knee Pain Scale)
Status
Active, Not Recruiting
Last Updated
7 months ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
June 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Martin Lind

Professor, PhD, MD

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Kujala (Anterior Knee Pain Scale)

Time Frame: 24 month

Patient reported outcome score, 0=worst and 100=best

Secondary Outcomes

  • One-legged single hop for distance(24 month)
  • Donor site morbidity score, 0=worst and 100=best(24 month)
  • Numerical Rating Scale (NRS-pain score)(24 month)
  • Tegner (Activity Score)(24 month)
  • Knee pain(24 month)
  • One-legged triple hop for distance(24 month)
  • Side-to-side hop test(24 month)
  • Gluteus Medius Strength test(24 month)
  • Quadriceps Strength test(24 month)

Study Sites (1)

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