Status:
RECRUITING
Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Large Size
Eligibility:
All Genders
8+ years
Phase:
NA
Brief 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 ar...
Detailed Description
By "very large size" we mean a size greater than +3 SD (standard deviation) on the updated French reference curves. Most of the very large sizes are constitutional. The first step in the management o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04067596
Start Date
November 25 2019
End Date
June 1 2026
Last Update
September 6 2023
Active Locations (3)
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1
CHI Creteil
Créteil, France, 94000
2
Pôle médical de Sénart
Lieusaint, France
3
Hôpital privé Claude Galien
Quincy-sous-Sénart, France