Investigating tibial tubercle osteotomy's role in knee ligament reconstruction
A Randomized Clinical Pilot Trial Comparing Isolated Medial Patellofemoral Ligament Reconstruction to Medial Patellofemoral Ligament Reconstruction Combined with Tibial Tubercle Osteotomy: SHould You TransFer the Tubercle (SHYFT)?
This study is testing if adding a specific knee surgery called tibial tubercle osteotomy to a ligament reconstruction can help people with repeated knee dislocations feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 13 Years to 30 Years |
| Sex | All |
| Sponsor | Banff Sport Medicine Foundation Academic / other |
| Locations | 1 site (Canmore, Alberta) |
| Trial ID | NCT05759039 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of tibial tubercle osteotomy (TTO) on the outcomes of medial patellofemoral ligament reconstruction (MPFL-R) in patients experiencing recurrent lateral patellofemoral instability. The study will randomly assign participants to receive either an isolated MPFL-R or an MPFL-R combined with TTO, focusing on patients with an increased tibial tubercle-trochlear groove (TT-TG) distance. The trial will assess feasibility in terms of patient recruitment, adherence to protocols, and follow-up completion rates over a minimum of 12 months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 13-30 with symptomatic recurrent lateral patellofemoral instability and a TT-TG distance of 15mm or greater.
Not a fit: Patients with significant osteoarthritis, high-grade trochlear dysplasia, or those unable to complete outcome questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients with recurrent knee instability.
How similar studies have performed: While the approach of combining TTO with MPFL-R is being explored, the specific correlation of TT-TG distance with patient outcomes remains under-researched, indicating a novel aspect to this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 13-30 years * Symptomatic recurrent lateral patellofemoral instability * TT-TG ≥15mm measured on MRI or ≥18mm on CT scan * Closed physes (confirmed on knee x-rays) Exclusion Criteria: * Caton-Deschamps ratio ≥ 1.4 on lateral radiographs * Femoral anteversion ≥ 25 degrees on diagnostic imaging rotational profile * Tibial external rotation ≥ 45 degrees on diagnostic imaging rotational profile * High-grade trochlear dysplasia requiring trochleoplasty * Significant osteoarthritis on skyline plain imaging (Kellgren Lawrence grade ≥ 2) * A chondral lesion of the patellofemoral joint that is undergoing a cartilage restoration procedure. * Unable to complete computer-based outcome questionnaires * Pregnant (at 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: hiemstra@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.