Genu ValgusNCT01641354
Comparison of Two Surgical Techniques to Treat Knock Knees in Children
A study testing Hemiepiphysiodesis in people with Genu Valgus, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Genu Valgus
- What is being tested?
- Hemiepiphysiodesis
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- genu valgus
- remaining growth
Who cannot join
- systemic disease
- unilateral disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reversible Hemiepiphysiodesis in Children - Stapling Versus Eight Plate
Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.
Read the detailed description
Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.
- Conditions
- Genu Valgus
- Being tested
- Hemiepiphysiodesis
- Keywords
- Hemiepiphysiodesis
- Medical subject headings
- Genu Valgum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemiepiphysiodesisProcedure or surgery
Partial closure of growth plate to correct deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment time
Measured: up to 3 years
Secondary outcomes (1)
Pain score post operatively
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionJul 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Genu ValgusStudies of the same condition, open and under way.
- More trials run by Aarhus 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gottliebsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641354
- Sponsor's protocol ID
- M-20080179
- Other IDs
- J.nr. 2009-41-3248
- Status last verified
- Jul 2012
- First submitted
- 7 Jun 2010
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gottliebsen M, Rahbek O, Hvid I, Davidsen M, Hellfritzsch MB, Moller-Madsen B. Hemiepiphysiodesis: similar treatment time for tension-band plating and for stapling: a randomized clinical trial on guided growth for idiopathic genu valgum. Acta Orthop. 2013 Apr;84(2):202-6. doi: 10.3109/17453674.2013.782526. Epub 2013 Mar 14.
PubMed 23485073
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversible Hemiepiphysiodesis in Children - Stapling Versus Eight Plate
- ClinicalTrials.gov ID
- NCT01641354
- Acronym / sponsor ID
- M-20080179
- Conditions
- Genu Valgus
- Keywords
- Hemiepiphysiodesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 16 Jul 2012 (estimated)
- 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.
Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.
Detailed description
Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- genu valgus
- remaining growth
Key exclusion criteria (2 listed)
- systemic disease
- unilateral disease
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 |
|---|---|---|
| HemiepiphysiodesisPartial closure of growth plate to correct deformity | Procedure or surgery | – |
Primary outcome
Treatment time
Time frame: up to 3 years
1 secondary outcome
Pain score post operatively
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
- Derived from this study: PubMed 23485073Gottliebsen M, Rahbek O, Hvid I, Davidsen M, Hellfritzsch MB, Moller-Madsen B. Hemiepiphysiodesis: similar treatment time for tension-band plating and for stapling: a randomized clinical trial on guided growth for idiopathic genu valgum. Acta Orthop. 2013 Apr;84(2):202-6. doi: 10.3109/17453674.2013.782526. Epub 2013 Mar 14.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiepiphysiodesis in people with Genu Valgus, run by Aarhus University Hospital at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Jul 2012. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment time (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01641354, which also lists 1 linked publication.
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 16 Jul 2012.