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

NCT06169800 | Recruiting FDA Device

• 1 other identifier: REB23-1095
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  2-years

Secondary Outcomes (9)

• Banff Patellofemoral Instability Instrument (BPII 2.0)

  2-years

• Single-leg Hop tests

  2-years

• Single-leg Balance test

  2-years

• Isometric Muscle Strength

  2-years

• Recurrent Instability of the Patella (RIP) Score

  2-years

Study Arms (1)

MPFL repair with Biobrace augmentation

EXPERIMENTAL

Patients presenting with first-time lateral patellofemoral dislocation within the previous 7 days will be offered a patellofemoral stabilization procedure, including knee arthroscopy and an MPFL repair augmented with Biobrace® synthetic ligament.

Device: MPFL repair with Biobrace augmentation

Interventions

MPFL repair with Biobrace augmentation DEVICE

MPFL repair with Biobrace augmentation

MPFL repair with Biobrace augmentation

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Banff Sport Medicine Foundation: lead
• CONMED Corporation: collaborator

Study Sites (1)

Banff Sport Medicine

Canmore, Alberta, T1W 0L5, Canada

RECRUITING

Study Officials

• Laurie A Hiemstra, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie A Hiemstra, MD, PhD

CONTACT

403 760 2897; research@banffsportmed.ca

Sarah Kerslake, BPT

CONTACT

403 760 2897; sarah@banffsportmed.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This investigator-initiated pilot trial will assess patients with a first-time lateral patellofemoral dislocation following surgical MPFL repair augmented with a Biobrace®. Patients will be evaluated for two years post-operative, using patient-reported outcome measures and objective clinical and functional testing.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 14, 2023
• Study Start: January 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)