Knee Function in Patients With Two or More Episodes of Patella Dislocations
NCT ID: NCT02263807
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2010-05-31
2022-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MPFL group
Arthroscopy and MPFL reconstruction
MPFL Group
MPFL reconstruction or standard treatment followed by physiotherapy
Control
Arthroscopy followed by active rehabilitation
Control
Arhroscopy and rehabilitation
Control
Arthroscopy followed by active rehabilitation
Interventions
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MPFL Group
MPFL reconstruction or standard treatment followed by physiotherapy
Control
Arthroscopy followed by active rehabilitation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Norwegian citizens
* Unilateral problems
* Age range 12-30 years
Exclusion Criteria
12 Years
30 Years
ALL
Yes
Sponsors
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Asbjorn Aroen
OTHER
Responsible Party
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Asbjorn Aroen
Professor, Orthopaedic Surgeon
Principal Investigators
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Asbjørn Årøen, MD,PhD
Role: STUDY_CHAIR
University Hospital, Akershus
Locations
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Akershus University Hospital
Lørenskog, , Norway
Akershus University Hospital
Lørenskog, , Norway
Countries
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References
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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.
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.
Nilsgard TL, Oiestad BE, Randsborg PH, Aroen A, Straume-Naesheim TM. Association between single leg hop tests and patient reported outcome measures and patellar instability in patients with recurrent patellar dislocations. BMJ Open Sport Exerc Med. 2023 Dec 30;9(4):e001760. doi: 10.1136/bmjsem-2023-001760. eCollection 2023.
Other Identifiers
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2009/2148
Identifier Type: -
Identifier Source: org_study_id
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