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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
Sponsor:
Collaborator:
surgebright GmbH
Information provided by (Responsible Party):
Dr. Thorsten Huber, Klinikum Wels-Grieskirchen

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.

Condition or disease Intervention/treatment
Hallux Valgus 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. incidence of surgical revisions [ Time Frame: 1 year ]
    Was a surgical revision done postoperatively? YES/NO

  2. incidence of loosening of the screw [ Time Frame: 1 year ]
    based on x-rays: Is a loosening of the screw visible? YES/NO

  3. incidence of cracking of the screw [ Time Frame: 1 year ]
    based on x-rays: Is a cracking of the screw visible? YES/NO

  4. Hallux valgus angle [ Time Frame: 1 year ]
    based on x-rays: What ist he Hallux valgus angle? °

  5. Intermetatarsal angle [ Time Frame: 1 year ]
    based on x-rays: What is the intermetatarsal angle? °

  6. incidence of postoperative pseudoarthrosis [ Time Frame: 1 year ]
    based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO

  7. 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.

  8. duration of postoperative job-related incapacity [ Time Frame: 1 year ]
    evaluation of duration


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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Austria
Klinikum Wels-Grieskirchen Recruiting
Wels, Oberösterreich, Austria, 4600
Contact: Stefan Hofstätter, Priv. Doz. Dr.    00436503838792    stefan.hofstätter@klinikum-wegr.at   
Contact: Thorsten Huber, Dr.    +43724241593462    thorsten.huber@klinikum-wegr.at   
A.ö. Bezirkskrankenhaus St. Johann in Tirol Recruiting
Sankt Johann In Tirol, Tirol, Austria, 6380
Contact: Thomas Herz, Dr.    0043 5352 606    herz@khsj.at   
Sponsors and Collaborators
Klinikum Wels-Grieskirchen
surgebright GmbH
Additional Information:

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Responsible Party: Dr. Thorsten Huber, Assistent surgeon, team member of the foot team, Klinikum Wels-Grieskirchen
ClinicalTrials.gov Identifier: NCT03884907    
Other Study ID Numbers: 1032/2018
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Thorsten Huber, Klinikum Wels-Grieskirchen:
human bone graft screw
foot and ankle surgery
hallux valgus deformity
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired