Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01645267
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Duration (Months): 36

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Flatfoot	Procedure: Hydroxyapatite	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyappatite / β- Tricalcium Phosphate Bone Substitute
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2012
• Anticipated Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Osteotomy Using hydroxyapatite bone graft material	Procedure: Hydroxyapatite; Use of artifical bonegraft material

Outcome Measures

Primary Outcome Measures

1. Healing of osteotomy [up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Flatfoot condition needing surgery

Exclusion Criteria:

• Traumatic conditions

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

• Principal Investigator: Martin Gottliebsen, PhD-student, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Gottliebsen, PhD-student, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT01645267
• Other Study ID Numbers: M-20090162
• First Posted: Jul 20, 2012
• Last Update Posted: Jul 20, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Flatfoot

Study Results

No Results Posted as of Jul 20, 2012