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Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis

NCT04067596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Large Size

Interventions

PROCEDURE

epiphysiodesis

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.

Sponsors & Collaborators

  • Centre Hospitalier Intercommunal Creteil

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067596 on ClinicalTrials.gov