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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067596
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

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.

Condition or disease Intervention/treatment Phase
Large Size Procedure: epiphysiodesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Very Large Sizes in Adolescents: Interest of the Tibial and Femoral EPIphysiodesis in Case of Request for Treatment.
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2025

Arm Intervention/treatment
Experimental: epiphysiodesis
The procedure consists of sterilizing the growth cartilage of the various localizations (distal femur and proximal tibia).
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.





Primary Outcome Measures :
  1. Final size (cm) [ Time Frame: 5 years ]
    Final size standing compared to the predicted size.

  2. Number of surgery adverse events [ Time Frame: 1 month ]
    Number of adverse events following surgery.

  3. Number of orthopedic adverse events [ Time Frame: 1 month ]
    Number of orthopedic adverse events following short-term and long-term clinical and radiological (EOS) surgery.

  4. Sitting height (cm) [ Time Frame: 1 month ]
    Sitting height and span before and after surgery.

  5. Satisfaction of patient and parents [ Time Frame: 5 years ]
    Adolescent and parental satisfaction with surgical management (verbatim analysis)



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067596


Contacts
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Contact: Camille JUNG, MD 01 57 02 22 68 camille.jung@chicreteil.fr

Locations
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France
CHI Creteil Recruiting
Créteil, France, 94000
Contact: Isis MARCHAND, MD    01 57 02 53 91    Isis.Marchand@chicreteil.fr   
CHI Villeneuve St Georges Recruiting
Villeneuve-Saint-Georges, France, 94190
Contact: Elodie GAUMETOU, MD       Elodie.Gaumetou@chiv.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04067596    
Other Study ID Numbers: GREPI
2018-A00950-55 ( Other Identifier: ID-RCB )
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No