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Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft

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ClinicalTrials.gov Identifier: NCT01618812
Recruitment Status : Unknown
Verified June 2012 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : June 13, 2012
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment
Pes Plano Valgus Flatfeet Procedure: Lateral lengthening osteotomy of calcaneus

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.

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute
Study Start Date : September 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
Drug Information available for: Durapatite
U.S. FDA Resources

Group/Cohort Intervention/treatment
Pes plano valgus
Children with painful flatfeet
Procedure: Lateral lengthening osteotomy of calcaneus
Use of artificial bone graft
Other Name: Hydroxyapatite



Primary Outcome Measures :
  1. Healing of osteotomy [ Time Frame: 104 weeks ]
    Will be followed with repeated clinical examinations until healing



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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01618812     History of Changes
Other Study ID Numbers: M-20090162
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities