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Active, not recruitingNCT06257836MPFLUpdated Oct 1, 2025

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

An observational study in Medial Patellofemoral Dislocation and Medial Patellofemoral Ligament Reconstruction, sponsored by Aarhus University Hospital. Active, not recruiting at 1 site in Denmark. Open to participants aged 14 Years to 23 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Aarhus University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
14 Years to 23 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Medial Patellofemoral Dislocation
  • Medial Patellofemoral Ligament Reconstruction

Keywords

  • MPFL, Knee, Medial Patellofemoral Ligament, Surgery
03

In context

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 23 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who have undergone MPFL quadriceps surgery as children in the period 2016-2022 at Aarhus University Hospital and have more than 2 years of follow-up. The patients will be 14-23 years old at the time of referral.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • MPFL reconstruction with quadriceps graft

    Children with medial patellofemoral reconstruction operated with epiphyses sparing quadriceps technique from 2016-2022.

    Other: MPFL-reconstruction

  • Healthy Cohort

    A healthy cohort matched on age (+/- 2 years) and gender

Interventions

  • OtherMPFL-reconstruction

    Children with patella dislocations are operated from 2016-2022 with a quadriceps knee cap stabilization technique.

06

What researchers measure

Primary outcomes

  1. Kujala (Anterior Knee Pain Scale)

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

    Time frame: 24 month

Secondary outcomes

  1. Donor site morbidity score, 0=worst and 100=best

    Patient reported outcome score

    Time frame: 24 month

  2. Numerical Rating Scale (NRS-pain score)

    Patient reported outcome score, 0=Best and 10=worst

    Time frame: 24 month

  3. Tegner (Activity Score)

    Patient reported outcome score, 0=worst and 10=best

    Time frame: 24 month

  4. 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)

    Time frame: 24 month

  5. One-legged single hop for distance

    Physical performance test

    Time frame: 24 month

  6. One-legged triple hop for distance

    Physical performance test

    Time frame: 24 month

  7. Side-to-side hop test

    Physical performance test

    Time frame: 24 month

  8. Quadriceps Strength test

    Physical performance test. Hand held dynamometry

    Time frame: 24 month

  9. Gluteus Medius Strength test

    Physical performance test. Hand held dynamometry

    Time frame: 24 month

07

Study locations

1 site
  • Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
    Aarhus N, 8200, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257836
Lead sponsor
Aarhus University Hospital
Responsible party
Martin Lind (Professor, PhD, MD, Aarhus University Hospital) — Principal investigator
First posted
Feb 14, 2024
Start date
Mar 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Oct 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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