search
Back to results

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
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flatfoot

Eligibility Criteria

8 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 12, 2012
    Last Updated
    July 19, 2012
    Sponsor
    Aarhus University Hospital
    search

    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

    Learn more about this trial

    Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft

    We'll reach out to this number within 24 hrs