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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Deformity of Limb; Anisomelia
• Intervention / Treatment: Other: Temporary hemi-epiphysiodesis or epiphysiodesis

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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Anne B Breen, MD; Phone Number: +47 92226905; Email: anneb3@ous-hf.no
• Study Contact Backup: Name: Joachim Horn, MD,PHD; Phone Number: +47 48047706; Email: jhorn@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet
    • Contact: Anne B Breen, MD; Phone Number: +47 92226905; Email: anneb3@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Axial deviations in children; Children with axial deviations in the lower extremity treated with guided growth	Other: Temporary hemi-epiphysiodesis or epiphysiodesis; Tension band plate (eight-plate, pedi plate), staple or locking plate
Limb length discrepancy in children; Children with limb length discrepancy treated with temporary epiphysiodesis	Other: Temporary hemi-epiphysiodesis or epiphysiodesis; Tension band plate (eight-plate, pedi plate), staple or locking plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis	Radiostereometric analysis of growth	4 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Joachim Horn, MD,PHD, Oslo Unversity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: LLD, guided growth
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 18/02287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No