beta
Trial Radar AI
Clinical Trial NCT04067596 (GREPI) for Large Size is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Very Large Sizes in Adolescents : Tibial and Femoral EPIphysiodesis (GREPI) 20 Adolescent

Recruiting
Clinical Trial NCT04067596 (GREPI) is an interventional study for Large Size that is recruiting. It started on 25 November 2019 with plans to enroll 20 participants. Led by Centre Hospitalier Intercommunal Creteil, it is expected to complete by 1 June 2026. The latest data from ClinicalTrials.gov was last updated on 6 September 2023.
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 tibi...Show More
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 of the paediatrician endocrinologist with very large body height is to collect the auxological parameters (family height, not just parental height, birth height, weight, height, head circumference, body mass index, height...

Show More
Official Title

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

Conditions
Large Size
Other Study IDs
  • GREPI
  • 2018-A00950-55 (Other Identifier) (ID-RCB)
NCT ID Number
NCT04067596
Start Date (Actual)
2019-11-25
Last Update Posted
2023-09-06
Completion Date (Estimated)
2026-06
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalepiphysiodesis
The procedure consists of sterilizing the growth cartilage of the various localizations (distal femur and proximal tibia).
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...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
8 Years
Eligible Sexes
All
  • 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

  • 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.
Centre Hospitalier Intercommunal Creteil logoCentre Hospitalier Intercommunal Creteil
Study Central Contact
Contact: Camille JUNG, MD, 01 57 02 22 68, [email protected]
3 Study Locations in 1 Countries
CHI Creteil, Créteil, 94000, France
Isis MARCHAND, MD, Contact, 01 57 02 53 91, [email protected]
Recruiting
Pôle médical de Sénart, Lieusaint, France
Elodie GAUMETOU, Contact
Recruiting
Hôpital privé Claude Galien, Quincy-sous-Sénart, France
Elodie GAUMETOU, Contact
Recruiting