About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- MPFL repair with Biobrace augmentation
Treatment groups
Sponsors and collaborators
Banff Sport Medicine Foundation
Lead sponsor
CONMED Corporation
Collaborator