Repair of the medial patellofemoral ligament to prevent knee dislocation recurrence
A Pilot Study to Evaluate the Effectiveness of a Biologic Augment of the Medial Patellofemoral Ligament to Reduce Recurrence After a Primary Lateral Patellofemoral Dislocation (BioPPD)
This study is testing if repairing a specific knee ligament with a special device can help young people aged 13 to 30 avoid having their kneecap dislocate again after their first dislocation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 13 Years to 30 Years |
| Sex | All |
| Sponsor | Banff Sport Medicine Foundation Academic / other |
| Locations | 1 site (Canmore, Alberta) |
| Trial ID | NCT06169800 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of medial patellofemoral ligament (MPFL) repair augmented with Biobrace® in reducing the rate of re-dislocation after a primary lateral patellofemoral dislocation. It focuses on young patients aged 13 to 30 who have experienced their first dislocation within the past week. The study aims to compare the re-dislocation rates two years post-surgery against the natural history of patellar instability, which has shown a significant recurrence rate. The innovative use of Biobrace® seeks to provide both biological support and strength during the healing phase.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 13 to 30 who have experienced their first lateral patellofemoral dislocation within the last 7 days.
Not a fit: Patients with a history of previous dislocations in the same knee or those with specific knee injuries requiring surgical repair may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of re-dislocation in young patients, improving their long-term knee stability and quality of life.
How similar studies have performed: While the approach of using Biobrace® for ligament augmentation is innovative, similar studies on MPFL repair have shown varying success rates in preventing re-dislocation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Canmore, Alberta
- Banff Sport Medicine — Canmore, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Laurie A Hiemstra, MD, PhD — University of Calgary
- Study coordinator: Laurie A Hiemstra, MD, PhD
- Email: research@banffsportmed.ca
- Phone: 403 760 2897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.