Pes PlanovalgusNCT01770574
New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures
A study testing ReproBone and calcaneal lengthening in people with Pes Planovalgus, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether structural calcium ceramic bone graft substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces postoperative pain. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Pes Planovalgus
- What is being tested?
- ReproBone and calcaneal lengthening
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to 10 Dec 2016
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 5-16 years with symptomatic planovalgus deformity admitted to the Department of Children's Orthopaedics, Aarhus University Hospital during the period 2012 to 2016. The surgical procedure is performed in about 10 children a year.
- Pain and/or callosities. Informed written consent from the child custody/guardianship. Ambulatory function No severe cognitive deficits
Who cannot join
- Reoperation will exclude patients from further follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structural HATCP Graft vs Tricortical Iliac Crest Autograft in Paediatric Calcaneal Lengthening Osteotomies: Interim Results From a Randomised Controlled Noninferiority Study
The purpose of this study is to determine whether structural calcium ceramic bone graft substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces postoperative pain.
To groups of patients (age 5-16) will be compared. One group randomized to autologous bone graft and the other group randomized to calcium ceramic.
The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog scale and numerical range scale).
Read the detailed description
Study C: HA-β TCP (ReproBone™) vs. autologous tricortical iliac crest bone graft in a calcaneal lengthening osteotomy in children with pes planovalgus. A clinical randomized controlled non-inferiority study with 12 months of follow-up.
Purpose. To investigate the clinical and radiographic findings of a calcaneal lengthening osteotomy by comparing autologous bonegraft and HA-β-TCP graft in a group of children with hindfoot valgus deformities. The primary outcome measure the stability of the osteotomy measured by migrations in the x-translation by RSA.
Design. Prospective, randomized controlled non-inferiority study.
Randomization: Children who fulfill the criteria for inclusion together with their parents/guardian receive information about the project. The patients are randomized to respectively HA-ß-TCP and iliac crest bone graft.
Surgical procedure: Calcaneal lengthening osteotomy is performed between the anterior and middle facet of the subtalar joint. The corticalis of the calcaneus is bilaterally cut through. The planovalgus deformity is corrected and with a graft matching the wedged osteotomy is inserted. Tantalum balls are inserted into calcaneus on each side of the osteotomy and in cuboideum. Postoperative pain treatment consist of a tibial nerve catheter which is used the first 24 hours. Patients in whom graft is harvested from the iliac crest get local infiltration analgesics accordingly to a standardized procedure. The pain is registered by the use of a visual analog scale (VAS, NRS, faces scale) a 3, 8 and 12 hours postoperative. The amounts of used analgesics are registered. The stability of the osteotomy is assessed by radiostereometric assay (RSA) at the following time points: Baseline (first/second postoperative day) after 6 weeks, 8 weeks, 6 months and 12 months.
Power and significance: The primary parameter is stability of the osteotomy, measured as x-translations by the RSA software. We used continuous non-inferiority sample size calculations. With alpha 0.05 and power 0.9, non-inferiority limit 2 mm and sd 1.5 mm we estimated the sample size to 10 patients in each group. To secure against drop-out, we plan to include 15 patients in each group.
For ethical considerations an interim analysis was planned when 10 patients completed 6 months RSA follow-up. Primary outcome was compression of the osteotomy. We used a 99.8% confidence interval.
- Conditions
- Pes Planovalgus
- Being tested
- ReproBone, calcaneal lengthening
- Keywords
- calcaneal lengthening, calcium ceramics, noninferiority, radiostereometric analysis
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReproBoneDevice
Also called Hydroxy-apatite-tricalcium-phosphate
Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy
calcaneal lengtheningProcedure or surgery
Also called Autologous bone graft
Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
| Study group | Role | What they receive |
|---|---|---|
| ReproBone | Experimental | calcaneal lengthening Receives: Device: ReproBone; Procedure: calcaneal lengthening |
| Autologous bone graft | Active comparator | calcaneal lengthening Receives: Procedure: calcaneal lengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric Analysis (RSA) of the calcaneal lengthening osteotomy
RSA examinations will be performed at baseline (first/second postoperative day), after 6 weeks, 8 weeks, 6 months and 12 months. Aim: To assess stability of the osteotomy and any micro motion in the neighbouring calcaneal-cuboid joint.
Measured: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months
Secondary outcomes (1)
General Pain
Pain will be assessed as general pain, by VAS/NRS/faces scaling at baseline (pre-op), 3 hrs, 5 hrs, 8 hrs, 12 hrs after surgery. Although minor changes in the specific time points can occur if the child is sleeping, since it would be unethical to wake them up.
Measured: The first 24 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completion1 Dec 2016
- Study completion10 Dec 2016
Why it stopped: Interim results showed that the HATCP material was not non-inferior to the AUTO graft.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanovalgusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Ceramisys Ltd
- Responsible party
- Sponsor
- Investigators
- Bjarne Møller-Madsen, DMSc, Prof, Study director, Department of Children's Orthopaedics Aarhus University HospitalPolina Martinkevich, PhD-student, Principal investigator, Department of Children's Orthopaedics Aarhus University HospitalOle Rahbek, Assoc prof PhD MD, Study chair, Department of Children's Orthopaedics, Aarhus University HospitalMartin Gottliebsen, MD PhD-stud, Study chair, Department of Children's Orthopaedics, Aarhus University HospitalMaiken Stilling, MD, PhD, Study chair, Department of Orthopaedics, Aarhus University HospitalLine Kjeldgaard Pedersen, MD, PhD, Study chair, Department of Children's Orthopaedics, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770574
- Sponsor's protocol ID
- 1-10-72-250-12
- Other IDs
- Interventional
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2012
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural HATCP Graft vs Tricortical Iliac Crest Autograft in Paediatric Calcaneal Lengthening Osteotomies: Interim Results From a Randomised Controlled Noninferiority Study
- ClinicalTrials.gov ID
- NCT01770574
- Acronym / sponsor ID
- 1-10-72-250-12
- Conditions
- Pes Planovalgus
- Keywords
- calcaneal lengthening, calcium ceramics, noninferiority, radiostereometric analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim results showed that the HATCP material was not non-inferior to the AUTO graft.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Ceramisys Ltd
- Study start
- Feb 2013
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 18 Jan 2013 (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.
The purpose of this study is to determine whether structural calcium ceramic bone graft substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces postoperative pain.
To groups of patients (age 5-16) will be compared. One group randomized to autologous bone graft and the other group randomized to calcium ceramic.
The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog scale and numerical range scale).
Detailed description
Study C: HA-β TCP (ReproBone™) vs. autologous tricortical iliac crest bone graft in a calcaneal lengthening osteotomy in children with pes planovalgus. A clinical randomized controlled non-inferiority study with 12 months of follow-up.
Purpose. To investigate the clinical and radiographic findings of a calcaneal lengthening osteotomy by comparing autologous bonegraft and HA-β-TCP graft in a group of children with hindfoot valgus deformities. The primary outcome measure the stability of the osteotomy measured by migrations in the x-translation by RSA.
Design. Prospective, randomized controlled non-inferiority study.
Randomization: Children who fulfill the criteria for inclusion together with their parents/guardian receive information about the project. The patients are randomized to respectively HA-ß-TCP and iliac crest bone graft.
Surgical procedure: Calcaneal lengthening osteotomy is performed between the anterior and middle facet of the subtalar joint. The corticalis of the calcaneus is bilaterally cut through. The planovalgus deformity is corrected and with a graft matching the wedged osteotomy is inserted. Tantalum balls are inserted into calcaneus on each side of the osteotomy and in cuboideum. Postoperative pain treatment consist of a tibial nerve catheter which is used the first 24 hours. Patients in whom graft is harvested from the iliac crest get local infiltration analgesics accordingly to a standardized procedure. The pain is registered by the use of a visual analog scale (VAS, NRS, faces scale) a 3, 8 and 12 hours postoperative. The amounts of used analgesics are registered. The stability of the osteotomy is assessed by radiostereometric assay (RSA) at the following time points: Baseline (first/second postoperative day) after 6 weeks, 8 weeks, 6 months and 12 months.
Power and significance: The primary parameter is stability of the osteotomy, measured as x-translations by the RSA software. We used continuous non-inferiority sample size calculations. With alpha 0.05 and power 0.9, non-inferiority limit 2 mm and sd 1.5 mm we estimated the sample size to 10 patients in each group. To secure against drop-out, we plan to include 15 patients in each group.
For ethical considerations an interim analysis was planned when 10 patients completed 6 months RSA follow-up. Primary outcome was compression of the osteotomy. We used a 99.8% confidence interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReproBone | Experimental | Device: ReproBone, Procedure: calcaneal lengtheningcalcaneal lengthening |
| Autologous bone graft | Active comparator | Procedure: calcaneal lengtheningcalcaneal lengthening |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 5-16 years with symptomatic planovalgus deformity admitted to the Department of Children's Orthopaedics, Aarhus University Hospital during the period 2012 to 2016. The surgical procedure is performed in about 10 children a year.
- Pain and/or callosities. Informed written consent from the child custody/guardianship. Ambulatory function No severe cognitive deficits
Key exclusion criteria (1 listed)
- Reoperation will exclude patients from further follow-up
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 |
|---|---|---|
| ReproBoneAlso: Hydroxy-apatite-tricalcium-phosphateArtificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy | Device | ReproBone |
| calcaneal lengtheningAlso: Autologous bone graftAutologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy | Procedure or surgery | Autologous bone graft, ReproBone |
Primary outcome
Radiostereometric Analysis (RSA) of the calcaneal lengthening osteotomy
Time frame: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months
RSA examinations will be performed at baseline (first/second postoperative day), after 6 weeks, 8 weeks, 6 months and 12 months. Aim: To assess stability of the osteotomy and any micro motion in the neighbouring calcaneal-cuboid joint.
1 secondary outcome
General Pain
Time frame: The first 24 hrs after surgery
Results and safety
The study was stopped early (reason given: Interim results showed that the HATCP material was not non-inferior to the AUTO graft.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
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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.
Bjarne Møller-Madsen, DMSc, Prof study director
Department of Children's Orthopaedics Aarhus University Hospital
Polina Martinkevich, PhD-student principal investigator
Department of Children's Orthopaedics Aarhus University Hospital
Ole Rahbek, Assoc prof PhD MD study chair
Department of Children's Orthopaedics, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReproBone and calcaneal lengthening in people with Pes Planovalgus, 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: stopped early, as of the sponsor's last update on 2 Oct 2019. 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?
The study was stopped early (reason given: Interim results showed that the HATCP material was not non-inferior to the AUTO graft.). 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?
Radiostereometric Analysis (RSA) of the calcaneal lengthening osteotomy (time frame: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months). 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 2 Oct 2019.