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NCT Number: NCT04235517

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

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.

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Key information

Conditions

Anisomelia Deformity of Limb

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet

Oslo, 0424, Norway

Location status: Recruiting

Location contact

Anne B Breen, MD

CONTACT

[email protected]

92226905 ext. +47

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temporary hemi-epiphysiodesis or epiphysiodesis

Other

Tension band plate (eight-plate, pedi plate), staple or locking plate

Primary outcomes

  1. Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis

    Time frame: 4 years

    Radiostereometric analysis of growth

Study contacts

Contact information is provided by the study sponsor or research team.

Anne B Breen, MD

CONTACT

[email protected]

92226905 ext. +47

Joachim Horn, MD,PHD

CONTACT

[email protected]

48047706 ext. +47

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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