Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis (NCT04067596) | Clinical Trial Compass
RecruitingNot Applicable
Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis
France20 participantsStarted 2019-11-25
Plain-language summary
The very large sizes can be very disabling and at the origin of a difficult psychological experience. Some families are in demand for a growth-curbing treatment. Currently, only hormonal treatments are offered in France but they are at the origin of many side effects. Northern European countries applied a surgical technique, deviated from the one used for a long time in leg asymmetries, to sterilize the proximal tibial and distal femoral growth cartilage, with most of the growth taking place at this level. The goal of this project is to be able to offer this technique to families in demand.
Who can participate
Age range
8 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:
* Adolescent (e) consultant for very large size with a demand for growth inhibition
* Very large idiopathic or secondary height without any other etiological treatment possible
* Tanner score ≥ 3 for boys and ≥ 2 for girls
* A0 ≤ 14 years for boys and ≤ 12.5 years for girls
* A chronological age of 10 to 16 for boys and 8 to 14 for girls
* Actual size from minimum 167.5 cm to 10 years old to at least 180 cm to 16 years old for boys and from minimum 160 cm to 8 years old to at least 174 cm to 14 years old for girls
* Predicted height ≥ 198 cm for boys and ≥ ≥ 184 cm for girls (refer to chapter 6.6)
* Radiological persistence of tibial and femoral tibial cartilage estimated residual growth ≥ 8 cm
* Absence of psychological contraindication to a curbing treatment of growth
* Agreement of the holders of the parental authority and the teenager for a surgery of epiphysiodesis type
* Agreement of the holders of the parental authority and the teenager to take part in the study
* Affiliated to a social security scheme
Exclusion Criteria:
* Very large size related to a medically curable etiology (hypersecretion of growth hormone called acromegaly)
* Refusal of the holders of the parental authority or the teenager for a surgery of the epiphysiodesis type
* Refusal of the holders of the parental authority or the teenager to take part in the study
* Medical or psychological contraindication to 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.