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

Recruiting

• Conditions: Anisomelia; Deformity of Limb
• Interventions: Other: Temporary hemi-epiphysiodesis or epiphysiodesis

• Registration Number: NCT04235517
• Lead Sponsor: Oslo University Hospital

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.

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Axial deviations in children	Temporary hemi-epiphysiodesis or epiphysiodesis	Children with axial deviations in the lower extremity treated with guided growth
Limb length discrepancy in children	Temporary hemi-epiphysiodesis or epiphysiodesis	Children with limb length discrepancy treated with temporary epiphysiodesis

Primary Outcome Measures

Name	Time	Method
Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis	4 years	Radiostereometric analysis of growth

Trial Locations

Locations (1)

The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway