Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis

NCT04067596 | Recruiting

• 2 other identifiers: GREPI2018-A00950-55
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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 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

Outcome Measures

Primary Outcomes (5)

• Final size (cm)

  Final size standing compared to the predicted size.

  5 years

• Number of surgery adverse events

  Number of adverse events following surgery.

  1 month

• Number of orthopedic adverse events

  Number of orthopedic adverse events following short-term and long-term clinical and radiological (EOS) surgery.

  1 month

• Sitting height (cm)

  Sitting height and span before and after surgery.

  1 month

• Satisfaction of patient and parents

  Adolescent and parental satisfaction with surgical management (verbatim analysis)

  5 years

Study Arms (1)

epiphysiodesis

EXPERIMENTAL

The procedure consists of sterilizing the growth cartilage of the various localizations (distal femur and proximal tibia).

Procedure: epiphysiodesis

Interventions

epiphysiodesis PROCEDURE

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.

epiphysiodesis

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (3)

CHI Creteil

Créteil, 94000, France

RECRUITING

Pôle médical de Sénart

Lieusaint, France

RECRUITING

Hôpital privé Claude Galien

Quincy-sous-Sénart, France

RECRUITING

Central Study Contacts

Camille JUNG, MD

CONTACT

01 57 02 22 68; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 26, 2019
• Study Start: November 25, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)