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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Joint Instability

Intervention / Treatment
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* Procedure: MPFL Group
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than one luxation Norwegian citizens Unilateral problems Age range 12-30 years Exclusion Criteria: -Generalized degenerative changes

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPFL group<br>Arthroscopy and MPFL reconstruction | Procedure: MPFL Group<br>* MPFL reconstruction or standard treatment followed by physiotherapy<br>* Other names: MPFL surgery;Procedure: Control<br>* Arthroscopy followed by active rehabilitation<br>* Other names: Arthroscopy;|
| Active Comparator: Control<br>Arhroscopy and rehabilitation | Procedure: Control<br>* Arthroscopy followed by active rehabilitation<br>* Other names: Arthroscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Numbers of reoperation in the two treatment groups | 2011-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patella reluxation | Number of reluxation of patella in the two treatment groups | 2011-2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patella luxation