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New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures

NCT01770574 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-10-02

No results posted yet for this study

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.

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).

Conditions

  • Pes Planovalgus

Interventions

DEVICE

ReproBone

Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy

PROCEDURE

calcaneal lengthening

Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy

Sponsors & Collaborators

  • Ceramisys Ltd

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Bjarne Møller-Madsen, DMSc, Prof · Department of Children's Orthopaedics Aarhus University Hospital

  • Polina Martinkevich, PhD-student · Department of Children's Orthopaedics Aarhus University Hospital

  • Ole Rahbek, Assoc prof PhD MD · Department of Children's Orthopaedics, Aarhus University Hospital

  • Martin Gottliebsen, MD PhD-stud · Department of Children's Orthopaedics, Aarhus University Hospital

  • Maiken Stilling, MD, PhD · Department of Orthopaedics, Aarhus University Hospital

  • Line Kjeldgaard Pedersen, MD, PhD · Department of Children's Orthopaedics, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-12-01
Completion
2016-12-10

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770574 on ClinicalTrials.gov