Medial Patellofemoral DislocationMPFLNCT06257836
Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study
An observational study of Medial Patellofemoral Dislocation and Medial Patellofemoral Ligament Reconstruction, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 14 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Medial Patellofemoral Dislocation, Medial Patellofemoral Ligament Reconstruction
- What is being tested?
- MPFL-reconstruction
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- MPFL-reconstruction with Quadriceps tendon graft
- Open physis at surgery date
- Minimum 2 years Follow up
- No knee problems
Who cannot join
- More surgeries in index knee
- MPFL-r in opposite knee
- MPFL revision in index knee
- None
- No knee problems
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Division of Sports Trauma, Palle Juul-Jensens Boulevard 99
Aarhus N, 8200
About this study
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.
- Being tested
- MPFL-reconstruction
- Keywords
- MPFL, Knee, Medial Patellofemoral Ligament, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPFL-reconstructionOther
Children with patella dislocations are operated from 2016-2022 with a quadriceps knee cap stabilization technique.
| Study group | Role | What they receive |
|---|---|---|
| MPFL reconstruction with quadriceps graft | Children with medial patellofemoral reconstruction operated with epiphyses sparing quadriceps technique from 2016-2022. Receives: Other: MPFL-reconstruction | |
| Healthy Cohort | A healthy cohort matched on age (+/- 2 years) and gender |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala (Anterior Knee Pain Scale)
Patient reported outcome score, 0=worst and 100=best
Measured: 24 month
Secondary outcomes (9)
Donor site morbidity score, 0=worst and 100=best
Patient reported outcome score
Measured: 24 month
Numerical Rating Scale (NRS-pain score)
Patient reported outcome score, 0=Best and 10=worst
Measured: 24 month
Tegner (Activity Score)
Patient reported outcome score, 0=worst and 10=best
Measured: 24 month
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)
Measured: 24 month
One-legged single hop for distance
Physical performance test
Measured: 24 month
One-legged triple hop for distance
Physical performance test
Measured: 24 month
Side-to-side hop test
Physical performance test
Measured: 24 month
Quadriceps Strength test
Physical performance test. Hand held dynamometry
Measured: 24 month
Gluteus Medius Strength test
Physical performance test. Hand held dynamometry
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Patellofemoral DislocationStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257836
- Sponsor's protocol ID
- Danish EC: 1-10-72-299-21
- Acronym
- MPFL
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Patellofemoral Ligament Reconstruction in Children - a 2-8 Years Follow-up Study
- ClinicalTrials.gov ID
- NCT06257836
- Acronym / sponsor ID
- MPFL / Danish EC: 1-10-72-299-21
- Keywords
- MPFL, Knee, Medial Patellofemoral Ligament, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPFL reconstruction with quadriceps graft | – | Other: MPFL-reconstructionChildren with medial patellofemoral reconstruction operated with epiphyses sparing quadriceps technique from 2016-2022. |
| Healthy Cohort | – | –A healthy cohort matched on age (+/- 2 years) and gender |
Who may qualify
- Ages
- 14 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- MPFL-reconstruction with Quadriceps tendon graft
- Open physis at surgery date
- Minimum 2 years Follow up
- No knee problems
Key exclusion criteria (5 listed)
- More surgeries in index knee
- MPFL-r in opposite knee
- MPFL revision in index knee
- None
- No knee problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPFL-reconstructionChildren with patella dislocations are operated from 2016-2022 with a quadriceps knee cap stabilization technique. | Other | MPFL reconstruction with quadriceps graft |
Primary outcome
Kujala (Anterior Knee Pain Scale)
Time frame: 24 month
Patient reported outcome score, 0=worst and 100=best
9 secondary outcomes
Donor site morbidity score, 0=worst and 100=best
Time frame: 24 month
Numerical Rating Scale (NRS-pain score)
Time frame: 24 month
Tegner (Activity Score)
Time frame: 24 month
Knee pain
Time frame: 24 month
One-legged single hop for distance
Time frame: 24 month
One-legged triple hop for distance
Time frame: 24 month
Side-to-side hop test
Time frame: 24 month
Quadriceps Strength test
Time frame: 24 month
Gluteus Medius Strength test
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medial Patellofemoral Dislocation and Medial Patellofemoral Ligament Reconstruction, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala (Anterior Knee Pain Scale) (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.