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

NCT ID: NCT04235517

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anisomelia Deformity of Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Axial deviations in children

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

Temporary hemi-epiphysiodesis or epiphysiodesis

Intervention Type OTHER

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

Temporary hemi-epiphysiodesis or epiphysiodesis

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Temporary hemi-epiphysiodesis or epiphysiodesis

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anne Berg Breen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joachim Horn, MD,PHD

Role: STUDY_CHAIR

Oslo Unversity Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet

Oslo, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne B Breen, MD

Role: CONTACT

92226905 ext. +47

Joachim Horn, MD,PHD

Role: CONTACT

48047706 ext. +47

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anne B Breen, MD

Role: primary

92226905 ext. +47

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18/02287

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.