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

NCT06169800 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-22

No results posted yet for this study

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.

Conditions

  • Patellofemoral Dislocation

Interventions

DEVICE

MPFL repair with Biobrace augmentation

MPFL repair with Biobrace augmentation

Sponsors & Collaborators

  • CONMED Corporation

    collaborator INDUSTRY

  • Banff Sport Medicine Foundation

    lead OTHER

Principal Investigators

  • Laurie A Hiemstra, MD, PhD · University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169800 on ClinicalTrials.gov