SHould You TransFer the Tubercle? (NCT05759039) | Clinical Trial Compass
RecruitingNot Applicable
SHould You TransFer the Tubercle?
Canada32 participantsStarted 2023-09-01
Plain-language summary
The aim of this study is to investigate the role of tibial tubercle osteotomy (TTO) on the subjective and objective outcomes following medial patellofemoral ligament reconstruction (MPFL-R) in patients with an increased tibial tubercle-trochlear groove (TT-TG) distance with or without patella alta.
This Pilot RCT will assess the feasibility of conducting this study for:
1. The ability to recruit study patients
2. Adherence to the study protocol
3. Completion rates of patient follow-up at a minimum of 12 months post-operative
Who can participate
Age range
13 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.