An interventional study of MPFL Group and Control in Joint Instability, sponsored by Asbjorn Aroen. Completed at 2 sites in Norway. Open to participants aged 12 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Asbjorn Aroen · Not applicable, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.
This study's enrollment of 61 is above the median of 46 across 58 interventional studies indexed under Joint Instability.
Browse Joint Instability studies →This is the only study on the registry with Asbjorn Aroen as lead sponsor.
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Exclusion Criteria:
-Generalized degenerative changes
Arthroscopy and MPFL reconstruction
Procedure: MPFL Group · Procedure: Control
Arhroscopy and rehabilitation
Procedure: Control
MPFL reconstruction or standard treatment followed by physiotherapy
Also known as: MPFL surgery
Arthroscopy followed by active rehabilitation
Also known as: Arthroscopy
Reoperation
Numbers of reoperation in the two treatment groups
Time frame: 2011-2022
Patella reluxation
Number of reluxation of patella in the two treatment groups
Time frame: 2011-2022
Ran from May 2010 to primary completion in Jan 2022, 140 months.
Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 140 months is above that.
Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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