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Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01618812
First received: June 11, 2012
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.


Condition Intervention
Pes Plano Valgus
Flatfeet
 Procedure: Lateral lengthening osteotomy of calcaneus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Healing of osteotomy [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
    Will be followed with repeated clinical examinations until healing


Estimated Enrollment: 10
Study Start Date: September 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pes plano valgus
Children with painful flatfeet
 Procedure: Lateral lengthening osteotomy of calcaneus
Use of artificial bone graft
Other Name: Hydroxyapatite

Detailed Description:

The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

  Eligibility

Ages Eligible for Study:   8 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

• children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.

Criteria

Inclusion Criteria:

  • pain
  • gait disturbance

Exclusion Criteria:

  • post traumatic conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618812

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Martin Gottliebsen, PhD-student Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01618812     History of Changes
Other Study ID Numbers: M-20090162
Study First Received: June 11, 2012
Last Updated: June 12, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Artificial bone graft
Hydroxyapatite
Children
 Osteotomy
Pes plano valgus
Flatfeet

Additional relevant MeSH terms:
Flatfoot
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013