Clinical trial NCT02263807: Knee Function in Patients With Two or More Episodes of Patella Dislocations
Official title: RCT Study:Knee Function in Patients With Two or More Episodes of Patella Dislocations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Instability
Keywords: Patella luxation
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Generalized degenerative changes

Primary outcomes:
measure: Reoperation
timeFrame: 2011-2022
Secondary outcomes:
measure: Patella reluxation
timeFrame: 2011-2022
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Asbjørn Årøen, MD,PhD
role: STUDY_CHAIR
References:
citation: Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.
citation: Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen 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. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.