Biologic Augment of the Medial Patellofemoral Ligament Following Primary Lateral Patellofemoral Dislocation (BioPPD)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-30
SponsorBanff Sport Medicine Foundation

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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Banff Sport Medicine Foundation

Lead sponsor

CONMED Corporation

Collaborator