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

NCT04235517 | Recruiting

• 1 other identifier: 18/02287
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anisomelia; Deformity of Limb

Keywords

LLD, guided growth

Outcome Measures

Primary Outcomes (1)

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

  Radiostereometric analysis of growth

  4 years

Study Arms (2)

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

Temporary hemi-epiphysiodesis or epiphysiodesis OTHER

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

Axial deviations in children; Limb length discrepancy in children

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Children with axial deviations and pathological physis

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet

Oslo, 0424, Norway

RECRUITING

Study Officials

• Joachim Horn, MD,PHD

  Oslo Unversity Hospital

  STUDY CHAIR

Central Study Contacts

Anne B Breen, MD

CONTACT

92226905; anneb3@ous-hf.no

Joachim Horn, MD,PHD

CONTACT

48047706; jhorn@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 22, 2020
• Study Start: January 1, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)