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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02263807
Other study ID # 2009/2148
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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