Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - Up to 7 days before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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