RecruitingNot ApplicableNCT06169800

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

A Pilot Study to Evaluate the Effectiveness of a Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After a Primary Lateral Patellofemoral Dislocation (BioPPD)


Sponsor

Banff Sport Medicine Foundation

Enrollment

20 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 13 YearsMax Age: 30 Years

Inclusion Criteria3

  • 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)

Exclusion Criteria4

  • 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

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Interventions

DEVICEMPFL repair with Biobrace augmentation

MPFL repair with Biobrace augmentation


Locations(1)

Banff Sport Medicine

Canmore, Alberta, Canada

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NCT06169800


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