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

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.

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: The patients will receive human bone graft screws surgically

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Wels, Oberösterreich, Austria, 4600
      • Recruiting
      • Klinikum Wels-Grieskirchen
      • Contact: Stefan Hofstätter, Priv. Doz. Dr.; Phone Number: 00436503838792; Email: stefan.hofstätter@klinikum-wegr.at
      • Contact: Thorsten Huber, Dr.; Phone Number: +43724241593462; Email: thorsten.huber@klinikum-wegr.at
  • Tirol
    • Sankt Johann In Tirol, Tirol, Austria, 6380
      • Recruiting
      • A.ö. Bezirkskrankenhaus St. Johann in Tirol
      • Contact: Thomas Herz, Dr.; Phone Number: 0043 5352 606; Email: herz@khsj.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of surgical revisions	Was a surgical revision done postoperatively? YES/NO	1 year
incidence of postoperative pseudoarthrosis	based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO	1 year
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
duration of postoperative job-related incapacity	evaluation of duration	1 year
incidence of loosening of the screw	based on x-rays: Is a loosening of the screw visible? YES/NO	1 year
incidence of cracking of the screw	based on x-rays: Is a cracking of the screw visible? YES/NO	1 year
Hallux valgus angle	based on x-rays: What ist he Hallux valgus angle? °	1 year
Intermetatarsal angle	based on x-rays: What is the intermetatarsal angle? °	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Klinikum Wels-Grieskirchen
• Collaborators: Surgebright Gmbh

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Anticipated): August 21, 2019
• Study Completion (Anticipated): March 21, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: human bone graft screw; foot and ankle surgery; hallux valgus deformity
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: 1032/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No