NCT06257836

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Mar 2024Jun 2026

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

February 6, 2024

Last Update Submit

September 30, 2025

Conditions

Keywords

MPFL, Knee, Medial Patellofemoral Ligament, Surgery

Outcome Measures

Primary Outcomes (1)

  • Kujala (Anterior Knee Pain Scale)

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

    24 month

Secondary Outcomes (9)

  • 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 single hop for distance

    24 month

  • +4 more secondary outcomes

Study Arms (2)

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

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

MPFL reconstruction with quadriceps graft

Eligibility Criteria

Age14 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • MPFL-reconstruction with Quadriceps tendon graft
  • Open physis at surgery date
  • Minimum 2 years Follow up

You may not qualify if:

  • More surgeries in index knee
  • MPFL-r in opposite knee
  • MPFL revision in index knee
  • No knee problems
  • None
  • No knee problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, MD

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

March 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations