NCT03884907

Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure

Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Klinikum Wels-Grieskirchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hallux Valgus

Interventions

Type	Name	Description
PROCEDURE	The patients will receive human bone graft screws surgically	All patients undergo Hallux valgus correction according to the Austin procedure using human bone graft screws.

Timeline

• Start date: 2018-03-21
• Primary completion: 2019-08-21
• Completion: 2020-03-21
• First posted: 2019-03-21
• Last updated: 2019-03-27

Locations

2 sites across 1 country: Austria