Surgical treatment for very tall adolescents to limit growth

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

This study is testing a surgery to help very tall teenagers limit their growth and avoid the side effects of hormone treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 8 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Intercommunal Creteil (Academic / other)
• Locations: 3 sites (Créteil and 2 other locations)
• Trial ID: NCT04067596 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to offer a surgical technique called epiphysiodesis to adolescents who are significantly taller than average and seek to limit their growth. The procedure targets the growth cartilage in the proximal tibia and distal femur to curb further height increase. Participants will undergo a thorough evaluation to confirm their eligibility based on height, growth patterns, and absence of other medical conditions. The study seeks to provide an alternative to hormonal treatments, which can have undesirable side effects.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 10 to 16 for boys and 8 to 14 for girls who are significantly taller than their peers and have a demand for growth inhibition.

Not a fit: Patients with growth issues due to hormonal causes or other underlying medical conditions may not benefit from this surgical intervention.

Why it matters

Potential benefit: If successful, this approach could provide a safe and effective method for managing excessive growth in adolescents, improving their quality of life.

How similar studies have performed: While surgical techniques for growth modulation have been applied in Northern European countries, this specific approach is relatively novel in the context of very tall adolescents in France.

Eligibility criteria

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.

Where this trial is running

Créteil and 2 other locations

• CHI Creteil — Créteil, France (Recruiting)
• Pôle médical de Sénart — Lieusaint, France (Recruiting)
• Hôpital privé Claude Galien — Quincy-sous-Sénart, France (Recruiting)

Study contacts

• Study coordinator: Camille JUNG, MD

Conditions Large Size