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

Joint Instability Clinical Trial

— MPFL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263807
• Other study ID #: 2009/2148
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: January 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• More than one luxation

• Norwegian citizens

• Unilateral problems

• Age range 12-30 years

Exclusion Criteria:

-Generalized degenerative changes

Related Conditions & MeSH terms

• Joint Instability
• Patellar Dislocation

Intervention

Procedure:
• MPFL Group
MPFL reconstruction or standard treatment followed by physiotherapy
• Control
Arthroscopy followed by active rehabilitation

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Akershus University Hospital	Lørenskog

Sponsors (1)

Lead Sponsor	Collaborator
Asbjorn Aroen

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Straume-Næsheim TM, Randsborg PH, Mikaelsen JR, Årøen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. — View Citation

Straume-Næsheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Årøen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Di — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Numbers of reoperation in the two treatment groups	2011-2022
Secondary	Patella reluxation	Number of reluxation of patella in the two treatment groups	2011-2022