NCT04367753

Brief Summary

Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery. The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care. The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 27, 2020

Last Update Submit

April 27, 2020

Conditions

Limb Length Discrepancy

Keywords

Epiphysiodesis

Outcome Measures

Primary Outcomes (6)

  • Limb length discrepancy before surgery

    3 months

  • Bones length

    3 months

  • Predictive bone growth

    3 months

  • Time limit between consultation and surgery

    3 months

  • Screw position in physis

    3 months

  • Bone age at the time of surgery

    3 months

Study Arms (2)

Fulfilled contract

The contract before the epiphysiodesis has been fulfilled with the wanted limb length at the final analysis

Failed contract

The contract before the epiphysiodesis hasn't been fulfilled with the wanted limb length at the final analysis

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All minors with limb length discrepancy who had epiphysiodesis surgery

You may qualify if:

  • Patients with limb length discrepancy who had epiphysiodesis surgery

You may not qualify if:

  • Missing x-rays
  • missing data
  • bone growth not achieved

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Hopitâl d'Enfants

Nancy, Lorraine, 54000, France

RECRUITING

Study Officials

  • Mathias KIRSCH

    CHU Hôpital d'Enfants Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Journeau

CONTACT

0683177822p.journeau@chru-nancy.fr

MathIas KIRSCH

CONTACT

0782931465mathias.kirsch@hotmail.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 29, 2020

Study Start

January 1, 2020

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

FR(1)