Clinical trial NCT03884907: Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure
Official title: Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hallux Valgus
Keywords: human bone graft screw
foot and ankle surgery
hallux valgus deformity
Lead sponsor: Klinikum Wels-Grieskirchen
Sponsor class: OTHER
Collaborators: name: Surgebright Gmbh
First posted: 2019-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from all participating sites scheduled for a Hallux valgus correction using the Austin procedure with human bone graft screws get information about this observational study and have the possibility to participate.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Indication for the use of a human bone graft in the surgical treatment of Hallux valgus treatment using Austin procedure
* legal capability of adults
* Written consent to participation in the study after previous written and oral education
* Age ≥ 18 years

Exclusion Criteria:

* Insufficient knowledge of the German language
* Alcohol and drug abuse
* Pregnant or breastfeeding woman
* Foreseeable compliance issues
* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
* Active osteomyelitis
* Ulcerations in the area of the skin of the surgical area
* Revision surgery after primary Hallux valgus surgery

Primary outcomes:
measure: incidence of surgical revisions
timeFrame: 1 year
measure: incidence of loosening of the screw
timeFrame: 1 year
measure: incidence of cracking of the screw
timeFrame: 1 year
measure: Hallux valgus angle
timeFrame: 1 year
measure: Intermetatarsal angle
timeFrame: 1 year
measure: incidence of postoperative pseudoarthrosis
timeFrame: 1 year
measure: evaluation postoperative pain (VAS)
timeFrame: 1 year
measure: duration of postoperative job-related incapacity
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction (VAS)
timeFrame: 1 year
measure: Assessment according to the AOFAS score
timeFrame: 1 year
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Oberösterreich
city: Sankt Johann In Tirol
country: Austria
facility: A.ö. Bezirkskrankenhaus St. Johann in Tirol
state: Tirol
Study officials:
References: