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

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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

Tracking Information
First Submitted Date March 20, 2019
First Posted Date March 21, 2019
Last Update Posted Date March 27, 2019
Actual Study Start Date March 21, 2018
Estimated Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2019)
  • 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.
Original Secondary Outcome Measures
 (submitted: March 20, 2019)
  • 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. All questions are to be answered realting tot he previous week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure
Official Title Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
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.

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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 21, 2020
Estimated Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884907
Other Study ID Numbers 1032/2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr. Thorsten Huber, Klinikum Wels-Grieskirchen
Study Sponsor Klinikum Wels-Grieskirchen
Collaborators surgebright GmbH
Investigators Not Provided
PRS Account Klinikum Wels-Grieskirchen
Verification Date March 2019