FlatfootNCT01645267
Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft
A study testing Hydroxyapatite in people with Flatfoot, run by Aarhus University Hospital.
Trial summary
In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Flatfoot
- What is being tested?
- Hydroxyapatite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Flatfoot condition needing surgery
Who cannot join
- Traumatic conditions
About this study
Official title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyappatite / β- Tricalcium Phosphate Bone Substitute
In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.
Read the detailed description
Planovalgus or flatfoot deformity is observed in children with different neuromuscular disorders and is associated with pain and gait disorders due to non-reducible talonavicular joint subluxation. Surgical treatment is aimed at correcting foot malalignement and achieving sufficient plantar flexion in the ankle joint. With a calcaneal lengthening osteotomy procedure the planovalgus deformity can be corrected but it requires the use of graft material to be inserted as a bone wedge at the osteotomy site. In this way the talonavicular joint is indirectly reduced. Obtaining autograft material from the iliac crest in growing children carries a risk of growth arrest and iliac wing deformity which has led to widespread use of allograft bone when performing the operation.
New materials are being developed as substitutes for bone graft material with biphasic calcium phosphate ceramic (BCP) being the most commonly used. BCP is a mixture of porous hydroxyapatite (HA) and β-tricalcium phosphate (β -TCP). Calcium phosphate ceramics have excellent biocompatibility and are thought to be able to facilitate and guide new bone growth. This has been demonstrated in experimental studies. In retrospective clinical studies on patients having filled large bone defects with hydroxyapatite graft material radiological healing is seen at follow ups after average 7.9 years. It has also previously been demonstrated that BCP can be used as artificial bone graft in osteotomies with a good result and complete healing of the osteotomi.
- Conditions
- Flatfoot
- Being tested
- Hydroxyapatite
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyapatiteProcedure or surgery
Use of artifical bonegraft material
| Study group | Role | What they receive |
|---|---|---|
| Osteotomy | Experimental | Using hydroxyapatite bone graft material Receives: Procedure: Hydroxyapatite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of osteotomy
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- Investigators
- Martin Gottliebsen, PhD-student, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645267
- Sponsor's protocol ID
- M-20090162
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 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 Hydroxyappatite / β- Tricalcium Phosphate Bone Substitute
- ClinicalTrials.gov ID
- NCT01645267
- Acronym / sponsor ID
- M-20090162
- Conditions
- Flatfoot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 20 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.
In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.
Detailed description
Planovalgus or flatfoot deformity is observed in children with different neuromuscular disorders and is associated with pain and gait disorders due to non-reducible talonavicular joint subluxation. Surgical treatment is aimed at correcting foot malalignement and achieving sufficient plantar flexion in the ankle joint. With a calcaneal lengthening osteotomy procedure the planovalgus deformity can be corrected but it requires the use of graft material to be inserted as a bone wedge at the osteotomy site. In this way the talonavicular joint is indirectly reduced. Obtaining autograft material from the iliac crest in growing children carries a risk of growth arrest and iliac wing deformity which has led to widespread use of allograft bone when performing the operation.
New materials are being developed as substitutes for bone graft material with biphasic calcium phosphate ceramic (BCP) being the most commonly used. BCP is a mixture of porous hydroxyapatite (HA) and β-tricalcium phosphate (β -TCP). Calcium phosphate ceramics have excellent biocompatibility and are thought to be able to facilitate and guide new bone growth. This has been demonstrated in experimental studies. In retrospective clinical studies on patients having filled large bone defects with hydroxyapatite graft material radiological healing is seen at follow ups after average 7.9 years. It has also previously been demonstrated that BCP can be used as artificial bone graft in osteotomies with a good result and complete healing of the osteotomi.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteotomy | Experimental | Procedure: HydroxyapatiteUsing hydroxyapatite bone graft material |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Flatfoot condition needing surgery
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| HydroxyapatiteUse of artifical bonegraft material | Procedure or surgery | Osteotomy |
Primary outcome
Healing of osteotomy
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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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.
Martin Gottliebsen, PhD-student principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyapatite in people with Flatfoot, run by Aarhus University Hospital.
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 1 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 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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: up to 1 year). 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 20 Jul 2012.