Hallux Valgus Clinical Trial
Official title:
Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.
For the treatment of bone fractures metal screws have been used for decades. Removal of
material is the major disadvantage of conventional osteosynthesis and requires a second
intervention, with all the complications and risks for each patient. Moreover, the metal
screw disturbs as foreign material in the bone and irritates the surrounding soft tissue.
In order to overcome the drawbacks of metal screws human bone screw grafts can be used
instead representing a biodegradable osteosynthesis material with ideal material properties.
The bone graft helps to create a solid, bony connection. This connection leads to an
extension, a bone remodeling, bone installation and optimal reparation process in the
affected area.
This observational study is being conducted in order to overcome the lack of systematic
research to objectively confirm the benefits of the product.
In total 50 patients will be enrolled in this study in several centers in Austria This
observational study will use Shark Screw® grafts manufactured by two tissue banks, the
Austrian Tissue Bank surgebright and the German Institute for Cell and Tissue Replacement
(DZIG). The Shark Screw® grafts were approved by the competent Austrian authority (AGES) in
2016.
All patients participating in this observational study, due to a medical indication, undergo
Hallux valgus correction according to the Austin procedure using the bone screws mentioned
above.
A 12 month postoperative observation period is set. Five routine follow-up examinations
including clinical examination and x-ray analysis will be performed. In case the an
additional routine follow-up examination is necessary for clinical reason within 24 month
post-operative, the patient remains in the study.
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