Hallux ValgusNCT03884907
Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure
An observational study of Hallux Valgus, run by Klinikum Wels-Grieskirchen at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- The patients will receive human bone graft screws surgically
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesAustria
- Study dates
- 21 Mar 2018to 21 Mar 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
A.ö. Bezirkskrankenhaus St. Johann in Tirol
Sankt Johann in Tirol, Tyrol, 6380
Thomas Herz, Dr., 0043 5352 606, herz@khsj.at
- Recruiting
Klinikum Wels-Grieskirchen
Wels, Upper Austria, 4600
Stefan Hofstätter, Priv. Doz. Dr., 00436503838792, stefan.hofstätter@klinikum-wegr.at
Thorsten Huber, Dr., +43724241593462, thorsten.huber@klinikum-wegr.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Hallux Valgus
- Being tested
- The patients will receive human bone graft screws surgically
- Keywords
- human bone graft screw, foot and ankle surgery, hallux valgus deformity
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The patients will receive human bone graft screws surgicallyProcedure or surgery
All patients undergo Hallux valgus correction according to the Austin procedure using human bone graft screws.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of surgical revisions
Was a surgical revision done postoperatively? YES/NO
Measured: 1 year
incidence of loosening of the screw
based on x-rays: Is a loosening of the screw visible? YES/NO
Measured: 1 year
incidence of cracking of the screw
based on x-rays: Is a cracking of the screw visible? YES/NO
Measured: 1 year
Hallux valgus angle
based on x-rays: What ist he Hallux valgus angle? °
Measured: 1 year
Intermetatarsal angle
based on x-rays: What is the intermetatarsal angle? °
Measured: 1 year
incidence of postoperative pseudoarthrosis
based on x-rays or MRI: Is a postoperative pseudoarthrosis visible? YES/NO
Measured: 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.
Measured: 1 year
duration of postoperative job-related incapacity
evaluation of duration
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start21 Mar 2018
- Primary completion21 Aug 2019 (estimated)
- Study completion21 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Klinikum Wels-Grieskirchen
- Sponsor type
- University, hospital or other
- Collaborators
- Surgebright Gmbh
- Responsible party
- Principal investigator, Dr. Thorsten Huber, Klinikum Wels-Grieskirchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884907
- Sponsor's protocol ID
- 1032/2018
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational Study on the Use of a Human Bone Graft in Austin Procedure of Hallux Valgus Correction
- ClinicalTrials.gov ID
- NCT03884907
- Acronym / sponsor ID
- 1032/2018
- Conditions
- Hallux Valgus
- Keywords
- human bone graft screw, foot and ankle surgery, hallux valgus deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Klinikum Wels-GrieskirchenUniversity, hospital or other
- Collaborators
- Surgebright Gmbh
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 21 Aug 2019 (estimated)
- Study completion
- 21 Mar 2020 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Insufficient knowledge of the German language
- Alcohol and drug abuse
- Pregnant or breastfeeding woman
- Foreseeable compliance issues
- Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The patients will receive human bone graft screws surgicallyAll patients undergo Hallux valgus correction according to the Austin procedure using human bone graft screws. | Procedure or surgery | – |
Primary outcome
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
2 secondary outcomes
Patient satisfaction (VAS)
Time frame: 1 year
Assessment according to the AOFAS score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by Klinikum Wels-Grieskirchen at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of surgical revisions (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.