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

Not Applicable

Completed

• Conditions: Joint Instability
• Interventions: Procedure: MPFL Group; Procedure: Control

• Registration Number: NCT02263807
• Lead Sponsor: Asbjorn Aroen

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-13
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

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

Exclusion Criteria

-Generalized degenerative changes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPFL group	MPFL Group	Arthroscopy and MPFL reconstruction
Control	Control	Arhroscopy and rehabilitation
MPFL group	Control	Arthroscopy and MPFL reconstruction

Primary Outcome Measures

Name	Time	Method
Reoperation	2011-2022	Numbers of reoperation in the two treatment groups

Secondary Outcome Measures

Name	Time	Method
Patella reluxation	2011-2022	Number of reluxation of patella in the two treatment groups

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway