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Recruiting NCT04235517

RSA Study on the Behaviour of the Growth Plate During and After Temporary Hemi-epiphysiodesis and Epiphysiodesis

Observational Anisomelia Deformity of Limb

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Temporary hemi-epiphysiodesis or epiphysiodesis.
Who it may be relevant to
Registry conditions: Anisomelia, Deformity of Limb. Basic parameters: 3 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Behaviour of the Growth Plate in Patients Operated With Either Permanent or Temporary Hemi-epiphysiodesis or Epiphysiodesis Through by the Use of Radiostereometric Analysis (RSA)

Overview

By using radiostereometric analysis (RSA) we will be able to study growth during and after temporary epiphysiodesis and with great accuracy be able to detect asymmetric growth following this procedure. By using the same method we also want to analyse patients with axial deviations operated with guided growth (tension band plating) to study the growth during and after the procedure and be able to set the correct timing for removal of the implant.

Detailed description

The RSA method consists of implantation of small tantalum beads on either side of the physis during surgery on the the physis. Later analysis of the RSA Pictures with the RSA-method will give us an microscopically accurate measure of the growth in three planes.

Interventions

  • Other Temporary hemi-epiphysiodesis or epiphysiodesis
    Tension band plate (eight-plate, pedi plate), staple or locking plate

Primary outcome measures

  • Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

  • Children with idiopathic axial deviations in the lower extremities
  • Children with limb length discrepancys where timing of epiphysiodesis is difficult because of a big discrepancy in skeletal age and chronological age

Exclusion criteria

  • Children with axial deviations and pathological physis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Norway · 1 center
  • The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet — Oslo

Identifiers

NCT: NCT04235517 · 18/02287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗