Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03884907|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment|
|Hallux Valgus||Procedure: The patients will receive human bone graft screws surgically|
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 [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction|
|Actual Study Start Date :||March 21, 2018|
|Estimated Primary Completion Date :||August 21, 2019|
|Estimated Study Completion Date :||March 21, 2020|
- 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.
- incidence of surgical revisions [ Time Frame: 1 year ]Was a surgical revision done postoperatively? YES/NO
- incidence of loosening of the screw [ Time Frame: 1 year ]based on x-rays: Is a loosening of the screw visible? YES/NO
- incidence of cracking of the screw [ Time Frame: 1 year ]based on x-rays: Is a cracking of the screw visible? YES/NO
- Hallux valgus angle [ Time Frame: 1 year ]based on x-rays: What ist he Hallux valgus angle? °
- Intermetatarsal angle [ Time Frame: 1 year ]based on x-rays: What is the intermetatarsal angle? °
- incidence of postoperative pseudoarthrosis [ Time Frame: 1 year ]based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
- 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
- Patient satisfaction (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 = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.
- Assessment according to the AOFAS score [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884907
|Wels, Oberösterreich, Austria, 4600|
|Contact: Stefan Hofstätter, Priv. Doz. Dr. 00436503838792 stefan.hofstätter@klinikum-wegr.at|
|Contact: Thorsten Huber, Dr. +43724241593462 email@example.com|
|A.ö. Bezirkskrankenhaus St. Johann in Tirol||Recruiting|
|Sankt Johann In Tirol, Tirol, Austria, 6380|
|Contact: Thomas Herz, Dr. 0043 5352 606 firstname.lastname@example.org|