Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft
Primary Purpose
Flatfoot
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hydroxyapatite
Sponsored by
About this trial
This is an interventional treatment trial for Flatfoot
Eligibility Criteria
Inclusion Criteria:
- Flatfoot condition needing surgery
Exclusion Criteria:
- Traumatic conditions
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osteotomy
Arm Description
Using hydroxyapatite bone graft material
Outcomes
Primary Outcome Measures
Healing of osteotomy
Secondary Outcome Measures
Full Information
NCT ID
NCT01645267
First Posted
July 12, 2012
Last Updated
July 19, 2012
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01645267
Brief Title
Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft
Official Title
Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyappatite / β- Tricalcium Phosphate Bone Substitute
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this foot deformity (plano valgus) surgery may be indicated. The deformity is corrected with an osteotomy at the heelbone. In most cases bone graft material has to be obtained from the iliac crest to support the osteotomy. In the planned study a group of children will be operated with an artificial bone graft material and thus avoiding the need harvesting of bone graft at the iliac crest.
Detailed Description
Planovalgus or flatfoot deformity is observed in children with different neuromuscular disorders and is associated with pain and gait disorders due to non-reducible talonavicular joint subluxation. Surgical treatment is aimed at correcting foot malalignement and achieving sufficient plantar flexion in the ankle joint. With a calcaneal lengthening osteotomy procedure the planovalgus deformity can be corrected but it requires the use of graft material to be inserted as a bone wedge at the osteotomy site. In this way the talonavicular joint is indirectly reduced. Obtaining autograft material from the iliac crest in growing children carries a risk of growth arrest and iliac wing deformity which has led to widespread use of allograft bone when performing the operation.
New materials are being developed as substitutes for bone graft material with biphasic calcium phosphate ceramic (BCP) being the most commonly used. BCP is a mixture of porous hydroxyapatite (HA) and β-tricalcium phosphate (β -TCP). Calcium phosphate ceramics have excellent biocompatibility and are thought to be able to facilitate and guide new bone growth. This has been demonstrated in experimental studies. In retrospective clinical studies on patients having filled large bone defects with hydroxyapatite graft material radiological healing is seen at follow ups after average 7.9 years. It has also previously been demonstrated that BCP can be used as artificial bone graft in osteotomies with a good result and complete healing of the osteotomi.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteotomy
Arm Type
Experimental
Arm Description
Using hydroxyapatite bone graft material
Intervention Type
Procedure
Intervention Name(s)
Hydroxyapatite
Intervention Description
Use of artifical bonegraft material
Primary Outcome Measure Information:
Title
Healing of osteotomy
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Flatfoot condition needing surgery
Exclusion Criteria:
Traumatic conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Gottliebsen, PhD-student
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft
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