RecruitingNot ApplicableNCT04067596

Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis

Very Large Sizes in Adolescents: Interest of the Tibial and Femoral EPIphysiodesis in Case of Request for Treatment.


Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

20 participants

Start Date

Nov 25, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 Years

Inclusion Criteria12

  • 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 Criteria4

  • 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.

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Interventions

PROCEDUREepiphysiodesis

The procedure consists of sterilizing the growth cartilage of the various localizations (distal femur and proximal tibia). Under general anesthesia under scopic control, the growth cartilage will be approached from both sides in order to curse the growth zone. This procedure is monitored throughout the procedure with iterative X-rays, to ensure complete curettage of the growth cartilage. The average duration of the intervention is 1 hour and a half. At the end of the procedure, there will be on each limb, 2 operative scars on each side of the knee, 8 scars in all. Closing will be done with resorbable stitches A simple dressing will be applied to each scar and a Zimmer splint in extension will be installed postoperatively to limit the painful mobilizations in acute phase.


Locations(3)

CHI Creteil

Créteil, France

Pôle médical de Sénart

Lieusaint, France

Hôpital privé Claude Galien

Quincy-sous-Sénart, France

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NCT04067596