New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures
NCT ID: NCT01770574
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2013-02-28
2016-12-10
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ReproBone
calcaneal lengthening
ReproBone
Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy
calcaneal lengthening
Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
Autologous bone graft
calcaneal lengthening
calcaneal lengthening
Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
Interventions
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ReproBone
Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy
calcaneal lengthening
Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Pain and/or callosities. Informed written consent from the child custody/guardianship. Ambulatory function No severe cognitive deficits
Exclusion Criteria
5 Years
16 Years
ALL
No
Sponsors
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Ceramisys Ltd
INDUSTRY
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Bjarne Møller-Madsen, DMSc, Prof
Role: STUDY_DIRECTOR
Department of Children's Orthopaedics Aarhus University Hospital
Polina Martinkevich, PhD-student
Role: PRINCIPAL_INVESTIGATOR
Department of Children's Orthopaedics Aarhus University Hospital
Ole Rahbek, Assoc prof PhD MD
Role: STUDY_CHAIR
Department of Children's Orthopaedics, Aarhus University Hospital
Martin Gottliebsen, MD PhD-stud
Role: STUDY_CHAIR
Department of Children's Orthopaedics, Aarhus University Hospital
Maiken Stilling, MD, PhD
Role: STUDY_CHAIR
Department of Orthopaedics, Aarhus University Hospital
Line Kjeldgaard Pedersen, MD, PhD
Role: STUDY_CHAIR
Department of Children's Orthopaedics, Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Other Identifiers
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Interventional
Identifier Type: OTHER
Identifier Source: secondary_id
1-10-72-250-12
Identifier Type: -
Identifier Source: org_study_id
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