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Completed

NCT Number: NCT02263807

Knee Function in Patients With Two or More Episodes of Patella Dislocations

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

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Key information

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Lørenskog, Norway

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About this study

Introduction:

Patella dislocation is a serious knee injury whose peak incidence occurs in patients aged 10-17 years and is associated with a high rate of re-dislocation. Knee injuries frequently cause long-term disability and reduced physical activity among adolescents and young persons. Surgery in this patient group requires a low tolerance for complications, meaning that physical therapy might offer more successful outcomes in many knee injury cases. The proposed project studies a particular patient cohort subjected to recurrent dislocation of the patella.

Aim:

The principal objective of this clinical, randomized controlled trial is to evaluate and compare knee function and symptoms in patients with recurrent patella dislocation randomized into treatment with surgical reconstruction of the medial patellofemoral ligament (MPFL) with those of patients in a standardized physiotherapy program designed to stabilize the patella and improve patient function.

Materials and methods:

Patients aged 12-30 years who have experienced two or more patella dislocations are randomized into groups receiving either MPFL reconstruction or physical therapy only. Follow-ups at 3, 6, 12, and 36 months involve functional tests, validated knee scores, arthroscopic examination, and cartilage-specific MRI protocols for the knee.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • More than one luxation
  • Norwegian citizens
  • Unilateral problems
  • Age range 12-30 years

Exclusion criteria

-Generalized degenerative changes

Treatment and study plan

MPFL Group

Procedure

MPFL reconstruction or standard treatment followed by physiotherapy

Other names: MPFL surgery

Control

Procedure

Arthroscopy followed by active rehabilitation

Other names: Arthroscopy

Primary outcomes

  1. Reoperation

    Time frame: 2011-2022

    Numbers of reoperation in the two treatment groups

Secondary outcomes

  1. Patella reluxation

    Time frame: 2011-2022

    Number of reluxation of patella in the two treatment groups

Sponsors and collaborators

Lead sponsor

Asbjorn Aroen

Other

Registry information

Official study title

RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations

Acronym: MPFL

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2014
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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