AnisomeliaNCT04235517
RSA Study on the Behaviour of the Growth Plate During and After Temporary Hemi-epiphysiodesis and Epiphysiodesis
An observational study of Anisomelia and Deformity of Limb, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Anisomelia, Deformity of Limb
- What is being tested?
- Temporary hemi-epiphysiodesis or epiphysiodesis
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2017to Jan 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- Child
Study population: Children with growth remaining and limb length discrepancy or axial deviations in the lower extremity
Who may be able to join
- 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
Who cannot join
- Children with axial deviations and pathological physis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
The Ortopedic dep at Oslo Unversity Hospital, Rikshospitalet
Oslo, 0424
Anne B Breen, MD, 92226905 ext. +47, anneb3@ous-hf.no
About this study
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)
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.
Read the 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.
- Conditions
- Anisomelia, Deformity of Limb
- Being tested
- Temporary hemi-epiphysiodesis or epiphysiodesis
- Keywords
- LLD, guided growth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary hemi-epiphysiodesis or epiphysiodesisOther
Tension band plate (eight-plate, pedi plate), staple or locking plate
| Study group | Role | What they receive |
|---|---|---|
| Axial deviations in children | Children with axial deviations in the lower extremity treated with guided growth Receives: Other: Temporary hemi-epiphysiodesis or epiphysiodesis | |
| Limb length discrepancy in children | Children with limb length discrepancy treated with temporary epiphysiodesis Receives: Other: Temporary hemi-epiphysiodesis or epiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis
Radiostereometric analysis of growth
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study startJan 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnisomeliaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Berg Breen, Oslo University Hospital
- Investigators
- Joachim Horn, MD,PHD, Study chair, Oslo Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235517
- Sponsor's protocol ID
- 18/02287
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04235517
- Acronym / sponsor ID
- 18/02287
- Conditions
- Anisomelia, Deformity of Limb
- Keywords
- LLD, guided growth
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial deviations in children | – | Other: Temporary hemi-epiphysiodesis or epiphysiodesisChildren with axial deviations in the lower extremity treated with guided growth |
| Limb length discrepancy in children | – | Other: Temporary hemi-epiphysiodesis or epiphysiodesisChildren with limb length discrepancy treated with temporary epiphysiodesis |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with growth remaining and limb length discrepancy or axial deviations in the lower extremity
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children with axial deviations and pathological physis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary hemi-epiphysiodesis or epiphysiodesisTension band plate (eight-plate, pedi plate), staple or locking plate | Other | Axial deviations in children, Limb length discrepancy in children |
Primary outcome
Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis
Time frame: 4 years
Radiostereometric analysis of growth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joachim Horn, MD,PHD study chair
Oslo Unversity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anisomelia and Deformity of Limb, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne B Breen, MD (92226905 ext. +47, anneb3@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.