Pes Plano ValgusNCT01618812
Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft
An observational study of Pes Plano Valgus and Flatfeet, run by University of Aarhus at 1 site in Denmark.
Trial summary
In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Pes Plano Valgus, Flatfeet
- What is being tested?
- Lateral lengthening osteotomy of calcaneus
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Apr 2013
- Phase
- Observational
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: • children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.
Who may be able to join
- pain
- gait disturbance
Who cannot join
- post traumatic conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute
In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.
Read the detailed description
The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.
- Conditions
- Pes Plano Valgus, Flatfeet
- Being tested
- Lateral lengthening osteotomy of calcaneus
- Keywords
- Artificial bone graft, Hydroxyapatite, Children, Osteotomy, Pes plano valgus, Flatfeet
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral lengthening osteotomy of calcaneusProcedure or surgery
Also called Hydroxyapatite
Use of artificial bone graft
| Study group | Role | What they receive |
|---|---|---|
| Pes plano valgus | Children with painful flatfeet Receives: Procedure: Lateral lengthening osteotomy of calcaneus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of osteotomy
Will be followed with repeated clinical examinations until healing
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionOct 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes Plano ValgusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Gottliebsen, PhD-student, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618812
- Sponsor's protocol ID
- M-20090162
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute
- ClinicalTrials.gov ID
- NCT01618812
- Acronym / sponsor ID
- M-20090162
- Conditions
- Pes Plano Valgus, Flatfeet
- Keywords
- Artificial bone graft, Hydroxyapatite, Children, Osteotomy, Pes plano valgus, Flatfeet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 13 Jun 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.
In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.
Detailed description
The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pes plano valgus | – | Procedure: Lateral lengthening osteotomy of calcaneusChildren with painful flatfeet |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- • children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.
Key inclusion criteria (2 listed)
- pain
- gait disturbance
Key exclusion criteria (1 listed)
- post traumatic conditions
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 |
|---|---|---|
| Lateral lengthening osteotomy of calcaneusAlso: HydroxyapatiteUse of artificial bone graft | Procedure or surgery | Pes plano valgus |
Primary outcome
Healing of osteotomy
Time frame: 104 weeks
Will be followed with repeated clinical examinations until healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
Related trials for Pes Plano Valgus
Not yet recruiting
Arthroereisis With Corrective Osteotomy Versus Arthroereisis Alone in Management of Symptomatic Flexible Pes Planovalgus in Adolescents
Pes Plano Valgus
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.
Martin Gottliebsen, PhD-student principal investigator
Aarhus University 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 Pes Plano Valgus and Flatfeet, run by University of Aarhus 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 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: status not confirmed, as of the sponsor's last update on 13 Jun 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?
Healing of osteotomy (time frame: 104 weeks). 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 13 Jun 2012.