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RecruitingNCT04235517Updated Sep 4, 2025

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

An observational study in Anisomelia and Deformity of Limb, sponsored by Oslo University Hospital. Recruiting at 1 site in Norway. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Oslo University Hospital · Observational

From the registry’s dates

  • Started Jan 2017; still recruiting 9 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
3 Years to 16 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Anisomelia
  • Deformity of Limb

Keywords

  • LLD, guided growth
03

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Children with growth remaining and limb length discrepancy or axial deviations in the lower extremity

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

Exclusion Criteria:

  • Children with axial deviations and pathological physis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Axial deviations in children

    Children with axial deviations in the lower extremity treated with guided growth

    Other: Temporary hemi-epiphysiodesis or epiphysiodesis

  • Limb length discrepancy in children

    Children with limb length discrepancy treated with temporary epiphysiodesis

    Other: Temporary hemi-epiphysiodesis or epiphysiodesis

Interventions

  • OtherTemporary hemi-epiphysiodesis or epiphysiodesis

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

06

What researchers measure

Primary outcomes

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

    Radiostereometric analysis of growth

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet
    Oslo, 0424, Norway
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04235517
Lead sponsor
Oslo University Hospital
Responsible party
Anne Berg Breen (Principal Investigator, Oslo University Hospital) — Principal investigator
First posted
Jan 22, 2020
Start date
Jan 2017
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Sep 4, 2025

Study contacts

Anne B Breen, MD
Contact
anneb3@ous-hf.no
92226905 ext. +47
Joachim Horn, MD,PHD
Contact
jhorn@ous-hf.no
48047706 ext. +47
Joachim Horn, MD,PHD
study chair · Oslo Unversity Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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