This study aims to determine the ability of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® to decrease the re-dislocation rate after a primary patellofemoral dislocation. First-time patellofemoral dislocation is a significant problem, and the ramifications of recurrence for patients are substantial. Due to the multifactorial nature of the pathoanatomy of patellofemoral instability, it has been difficult to design trials that will show how interventions could affect the natural history of these young patients. No definitive studies have determined whether the surgical reconstruction of the MPFL in patients with mild to moderate pathoanatomic risk factors will decrease the re-dislocation rate after a first-time dislocation. In addition, to date, no synthetic option has provided both biology and strength for ligament augmentation. This innovation may allow for a minimalist approach to keeping the patella centred in the trochlear groove during the healing phase after a first-time dislocation.
Age 13 - 30 years
First-time lateral patellofemoral dislocation in the previous 7 days
Closed or closing growth plates (confirmed on knee x-rays with no change required for surgical technique)
History of previous patellofemoral dislocation on the index knee
An osteochondral fracture of the patellofemoral joint that requires surgical repair
Unable to complete computer-based outcome questionnaires
Pregnant at the time of surgery
Single group
MPFL repair with Biobrace augmentation
DeviceMPFL repair with Biobrace augmentation
Recurrent Dislocation of the Patella
Reports of patellar dislocation will be recorded during the follow-up visits, and a clinical assessment of patellar mobility will be completed to assess the integrity of the MPFL to confirm the redislocation. The rate of re-dislocation will be calculated and compared with the published 30% recurrence rate for patients managed conservatively following a first-time patellar dislocation. A relative risk and risk difference of re-dislocation will be calculated.
Banff Patellofemoral Instability Instrument (BPII 2.0)
The BPII 2.0 is a valid and reliable, disease-specific quality-of-life score with five domains, including symptoms and physical complaints; work-related concerns; sport, recreation, and competition; lifestyle; and social and emotional. This patient-reported outcome will be assessed before surgery, and 6, 12, and 24 months after surgery. Score range 0-100, with higher score indicative of higher quality of life.
Single-leg Hop tests
The hop tests involve a comparative assessment of limb-to-limb function for a single hop for distance, a 6-metre timed hop, a triple hop for distance, and a triple cross-over hop at 6, 12, and 24 months after surgery.
Single-leg Balance test
Single-leg balance on a Bosu ball will be assessed for each limb to a maximum time of 30 seconds at 6, 12, and 24 months after surgery.
Isometric Muscle Strength
A crane gauge will be used to measure quadriceps and hamstrings strength in kilograms before surgery and 6, 12, and 24 months after surgery.
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Banff Sport Medicine Foundation
Lead sponsor
CONMED Corporation
Collaborator
