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

Deformity of Limb Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235517
• Other study ID #: 18/02287
• Status: Recruiting
• Start date: January 2017
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Oslo University Hospital
• Contact: Anne B Breen, MD
• Phone: 92226905
• Email: anneb3[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anisomelia
• Congenital Abnormalities
• Deformity of Limb

Intervention

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

Locations

Country	Name	City	State
Norway	The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis	Radiostereometric analysis of growth	4 years