NCT01770574

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

October 2, 2019

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

September 26, 2012

Last Update Submit

September 30, 2019

Conditions

Pes Planovalgus

Keywords

calcaneal lengtheningcalcium ceramicsnoninferiorityradiostereometric analysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Postoperative, 6 weeks, 8 weeks, 6 months, 12 months

Secondary Outcomes (1)

  • General Pain

    The first 24 hrs after surgery

Other Outcomes (2)

  • Pedobarography

    preoperative, 6 months, 12 months

  • OxAFQ

    preoperative, 6 months, 12 months

Study Arms (2)

ReproBone

EXPERIMENTAL

calcaneal lengthening

Device: ReproBoneProcedure: calcaneal lengthening

Autologous bone graft

ACTIVE COMPARATOR

calcaneal lengthening

Procedure: calcaneal lengthening

Interventions

ReproBoneDEVICE

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

Also known as: Hydroxy-apatite-tricalcium-phosphate
ReproBone
calcaneal lengtheningPROCEDURE

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

Also known as: Autologous bone graft
Autologous bone graftReproBone

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Reoperation will exclude patients from further follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bjarne Møller-Madsen, DMSc, Prof

    Department of Children's Orthopaedics Aarhus University Hospital

    STUDY DIRECTOR

  • Polina Martinkevich, PhD-student

    Department of Children's Orthopaedics Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Ole Rahbek, Assoc prof PhD MD

    Department of Children's Orthopaedics, Aarhus University Hospital

    STUDY CHAIR

  • Martin Gottliebsen, MD PhD-stud

    Department of Children's Orthopaedics, Aarhus University Hospital

    STUDY CHAIR

  • Maiken Stilling, MD, PhD

    Department of Orthopaedics, Aarhus University Hospital

    STUDY CHAIR

  • Line Kjeldgaard Pedersen, MD, PhD

    Department of Children's Orthopaedics, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2012

First Posted

January 18, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 10, 2016

Last Updated

October 2, 2019

Record last verified: 2016-07

Locations

DK(1)