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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884907
• Other study ID #: 1032/2018
• Status: Recruiting
• Start date: March 21, 2018
• Est. completion date: March 21, 2020

Study information

• Verified date: March 2019
• Source: Klinikum Wels-Grieskirchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 21, 2020
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

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.

Locations

Country	Name	City	State
Austria	A.ö. Bezirkskrankenhaus St. Johann in Tirol	Sankt Johann In Tirol	Tirol
Austria	Klinikum Wels-Grieskirchen	Wels	Oberösterreich

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Wels-Grieskirchen	surgebright GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of surgical revisions	Was a surgical revision done postoperatively? YES/NO	1 year
Primary	incidence of loosening of the screw	based on x-rays: Is a loosening of the screw visible? YES/NO	1 year
Primary	incidence of cracking of the screw	based on x-rays: Is a cracking of the screw visible? YES/NO	1 year
Primary	Hallux valgus angle	based on x-rays: What ist he Hallux valgus angle? °	1 year
Primary	Intermetatarsal angle	based on x-rays: What is the intermetatarsal angle? °	1 year
Primary	incidence of postoperative pseudoarthrosis	based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO	1 year
Primary	evaluation postoperative pain (VAS)	The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.	1 year
Primary	duration of postoperative job-related incapacity	evaluation of duration	1 year
Secondary	Patient satisfaction (VAS)	The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.	1 year
Secondary	Assessment according to the AOFAS score	AOFAS (American Orthopaedic Foot and Ankle Society) Score evaluates the functional impairments of food and ankle. The AOFAS score consists of 8 questions in the categories pain (40 points), function (6 questions, total 45 points) and alignment (15 points). The scores of all questions are summed up to the total score. The maximum score is 100, where 100 is the best outcome and 0 is the worst outcome. All questions are to be answered relating to the previous week.	1 year