Recruiting

Biologic Augment

Sponsor:

Banff Sport Medicine Foundation

Code:

NCT06169800

Conditions

Patellofemoral Dislocation

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

Interventions

MPFL repair with Biobrace augmentation

Study Details

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

Study ID

NCT06169800

Start date

Jan 15, 2024

Status verified date

Jan, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MPFL repair with Biobrace augmentation

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.

Interventions

MPFL repair with Biobrace augmentation

MPFL repair with Biobrace augmentation

Primary outcome measure

  • Recurrent Dislocation of the Patella [ Time Frame: 2-years ]

Central Contacts and Locations

Central contacts

Locations

Banff Sport Medicine

Recruiting

Canmore, Alberta, Canada, T1W 0L5

Contacts

Laurie Hiemstra, MD PhD FRCSC

403-760-2897hiemstra@banffsportmed.ca

More Information

Sponsor

Banff Sport Medicine Foundation

Last update posted

Oct 22, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Banff Sport Medicine Foundation on 2025-10-22.