Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- incidence of loosening of the screw
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
incidence of loosening of the screw
Time Frame: 1 year
based on x-rays: Is a loosening of the screw visible? YES/NO
Hallux valgus angle
Time Frame: 1 year
based on x-rays: What ist he Hallux valgus angle? °
incidence of cracking of the screw
Time Frame: 1 year
based on x-rays: Is a cracking of the screw visible? YES/NO
incidence of surgical revisions
Time Frame: 1 year
Was a surgical revision done postoperatively? YES/NO
incidence of postoperative pseudoarthrosis
Time Frame: 1 year
based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
Intermetatarsal angle
Time Frame: 1 year
based on x-rays: What is the intermetatarsal angle? °
evaluation postoperative pain (VAS)
Time Frame: 1 year
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.
duration of postoperative job-related incapacity
Time Frame: 1 year
evaluation of duration
Secondary Outcomes
- Patient satisfaction (VAS)(1 year)
- Assessment according to the AOFAS score(1 year)
Investigators
Dr. Thorsten Huber
Assistent surgeon, team member of the foot team
Klinikum Wels-Grieskirchen