Actively Recruiting

Phase Not Applicable
Age: 13Years - 30Years
All Genders
ID06169800

Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After Primary Lateral Patellofemoral Dislocation

Led by Banff Sport Medicine Foundation · Updated on 2025-10-22

20

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

B

Banff Sport Medicine Foundation

Lead Sponsor

C

CONMED Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether repairing the medial patellofemoral ligament (MPFL) with the help of a Biobrace4 implant can reduce the chance of the kneecap dislocating again after a first-time patellofemoral dislocation. Patellofemoral dislocation is a common knee injury, especially in young people, with recurrence rates varying widely depending on individual risk factors. Current treatments vary, and no clear consensus exists on the best approach to prevent repeat dislocations in patients with mild to moderate risk. Participants will undergo a surgical procedure within 7 days of their first lateral patellofemoral dislocation. This involves knee arthroscopy combined with MPFL repair that is enhanced by a synthetic Biobrace4 ligament designed to support both mechanical strength and biological healing. This intervention is being studied to see if it better maintains the kneecap's position during healing compared to natural outcomes without surgery. During the study, participants will be monitored for up to two years to assess if the patella dislocates again. Assessments include physical tests such as single-leg hop and balance, muscle strength measurements, and patient-reported outcome questionnaires related to knee instability, pain, medication use, and psychological factors. Close follow-up in the initial two weeks will monitor pain and medication use, while longer-term evaluations will focus on knee function and stability.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 13 to 30 years
  • First-time lateral patellofemoral dislocation within the previous 7 days
  • Closed or closing growth plates confirmed by knee X-rays
Not Eligible

You will not qualify if you...

  • Previous patellofemoral dislocation on the same knee
  • Osteochondral fracture of the patellofemoral joint requiring surgical repair
  • Unable to complete computer-based outcome questionnaires
  • Pregnant at the time of surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 7 days before surgery

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and initial recovery period

Participants undergo knee arthroscopy and medial patellofemoral ligament (MPFL) repair augmented with the Biobrace® synthetic ligament.

1 surgical visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 2 weeks for initial pain and medication monitoring; continued assessments up to 2 years

Participants are monitored for recovery, pain, medication use, and functional outcomes including strength and stability.

Multiple follow-up visits during the first 2 weeks and periodic assessments up to 2 years

Trial Site Locations

Total: 1 location

1

Banff Sport Medicine

Canmore, Alberta, Canada, T1W 0L5

Actively Recruiting

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Research Team

L

Laurie A Hiemstra, MD, PhD

S

Sarah Kerslake, BPT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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