Hallux ValgusNCT06262204
Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw).
A study testing Hallux Valgus Treatment with Shark Screw® and Hallux Valgus Treatment with metal screw in people with Hallux Valgus, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
Trial summary
The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Hallux Valgus Treatment with Shark Screw® and Hallux Valgus Treatment with metal screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 85
- confirmed Hallux Valgus
Who cannot join
- <18 years and >85 years
- Known underlying oncological disease
- Pregnant women or breastfeeding mothers
- Alcohol and drug abuse
- Foreseeable compliance problems
- Foreseeable loss of responsibility as a study doctor
Show all 10Show fewer
- Neoplastic diseases
- Active osteomyelitis
- Ulcerations in the area of the skin of the surgical site
- Immunosuppressive medication that cannot be discontinued
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andreas Kranzl, PhD contact
Austria1 site
Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising
Vienna, 1130
Florian Wenzel-Schwarz, MD, +43180182 ext. 3081, florian.wenzel-schwarz@oss.at
Florian Wenzel-Schwarz, MD
About this study
Official title: Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study
The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
The main questions it aims to answer are:
Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.
Read the detailed description
The planned prospective study will investigate whether the use of the human allogenic cortical bone screw (Shark Screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. Furthermore, it will be investigated whether rotational stability is possible with the bone screw. The measurement of the HVA angle and the IMA angle should provide information on whether the correction is stable over time. A comparison of the AOFAS forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results.
Initial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . A retrospective study by Hanslik-Schnabel et al has shown initial positive results in the treatment of hallux rigidus. In addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3D gait analysis/pedobarography and is also matched with another healthy cohort.
At the preoperative time point and after 12 and 24 months, a 3D gait analysis with a foot model is conducted to record the joint kinematics and kinetics. In the study by Canseco et al. , the proximal gait pattern changes remained unchanged. Hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux MP joint in the terminal standing phase.
- Conditions
- Hallux Valgus
- Being tested
- Hallux Valgus Treatment with Shark Screw®, Hallux Valgus Treatment with metal screw
- Keywords
- Hallux Valgus, human allogeneic cortical bone screw, Shark Screw®, HVA, IMA, AOFAS, time to union, union rate, FFI
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux Valgus Treatment with Shark Screw®Procedure or surgery
This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.
Hallux Valgus Treatment with metal screwProcedure or surgery
This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Other | standard surgery with metal screw Receives: Procedure: Hallux Valgus Treatment with metal screw |
| Shark Screw® group | Experimental | new surgical procedure with human allogeneic cortical bone screw Receives: Procedure: Hallux Valgus Treatment with Shark Screw® |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical result of Hallux Valgus treatment
The primary objective of the study is the longitudinal evaluation of clinical outcomes (pain, appearance) over 2 years after hallux correction using a human, allogenic, bone screw or metal screw.
Measured: 2 years
Secondary outcomes (5)
radiological (bony union)result of Hallux Valgus treatment
The secondary aim of the study is the longitudinal evaluation of the radiological results over one year after hallux correction using a human, allogenic, bone screw or metal screw compared to pre-surgery values.
Measured: 1 years
change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)
The change in forefoot-AOFAS will be evaluated, between groups and in comparison to pre-surgery
Measured: 2 years
Hallux-Valgus angle (HVA) change
Comparison of HVA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data
Measured: 2 years
gait analysis
Number of patients with normal gait in the two groups and in comparison to a healthy cohort
Measured: 2 years
Intermetatarsal angle (IMA) change
Comparison of IMA pre-surgery and after 6, 12 and 24 months after surgery, between groups and in comparison to pre-surgery data
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopedic Hospital Vienna Speising
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forian Wenzel-Schwarz, Orthopedic Hospital Vienna Speising
- Investigators
- Florian Wenzel-Schwarz, MD, Principal investigator, Orthopädisches Spital Speising
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262204
- Sponsor's protocol ID
- Hallux Shark Screw(R)
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to sensitivity of Data
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Comparison of Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw, a Prospective Study
- ClinicalTrials.gov ID
- NCT06262204
- Acronym / sponsor ID
- Hallux Shark Screw(R)
- Conditions
- Hallux Valgus
- Keywords
- Hallux Valgus, human allogeneic cortical bone screw, Shark Screw®, HVA, IMA, AOFAS, time to union, union rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Orthopedic Hospital Vienna SpeisingUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Feb 2024 (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.
The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
The main questions it aims to answer are:
Can the new method obtain comparable results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized.
Detailed description
The planned prospective study will investigate whether the use of the human allogenic cortical bone screw (Shark Screw® leads to comparable results in the union rate and the prevention of recurrences as with metal screws. Furthermore, it will be investigated whether rotational stability is possible with the bone screw. The measurement of the HVA angle and the IMA angle should provide information on whether the correction is stable over time. A comparison of the AOFAS forefoot score before and after the operation for both methods is a further measure to check whether the human allogenic cortical bone screw can deliver similar results.
Initial studies on the use of the allogenic bone screw in hand and foot surgery show particularly good integration behavior of the human allogenic cortical bone screw . A retrospective study by Hanslik-Schnabel et al has shown initial positive results in the treatment of hallux rigidus. In addition, a gait analysis is performed pre- and postoperatively to provide information on possible differences between the two groups in the context of 3D gait analysis/pedobarography and is also matched with another healthy cohort.
At the preoperative time point and after 12 and 24 months, a 3D gait analysis with a foot model is conducted to record the joint kinematics and kinetics. In the study by Canseco et al. , the proximal gait pattern changes remained unchanged. Hwang reported hyper-external rotation in the subtalar joint, excessive eversion in the subtalar joint, and lack of movement in the hallux MP joint in the terminal standing phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Other | Procedure: Hallux Valgus Treatment with metal screwstandard surgery with metal screw |
| Shark Screw® group | Experimental | Procedure: Hallux Valgus Treatment with Shark Screw®new surgical procedure with human allogeneic cortical bone screw |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18 and 85
- confirmed Hallux Valgus
Key exclusion criteria (10 listed)
- <18 years and >85 years
- Known underlying oncological disease
- Pregnant women or breastfeeding mothers
- Alcohol and drug abuse
- Foreseeable compliance problems
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 |
|---|---|---|
| Hallux Valgus Treatment with Shark Screw®This is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI. | Procedure or surgery | Shark Screw® group |
| Hallux Valgus Treatment with metal screwThis is a prospective, randomised study in which hallux valgus is corrected by means of a chevron/kin surgery technique using metal screws or human allogenic cortical bone screws (Shark Screw®, Surgebright, Lichtenberg, Austria). X-rays are taken before the operation at 6 weeks, three, six and twelve months after the operation. The X-ray images provide information on whether bony degeneration has taken place. In addition, the American Orthopaedic Foot \& Ankle Society (AOFAS) hallux score, FFI score, hallux valgus angle (HVA) and intermetatarsal angle (IMA) are determined. These data are collected preoperatively and 4 weeks (HVA and IMA), six and twelve months postoperatively in order to rule out a change in the HVA and IMA and to document the changes in the AOFAS/FFI. | Procedure or surgery | conventional group |
Primary outcome
clinical result of Hallux Valgus treatment
Time frame: 2 years
The primary objective of the study is the longitudinal evaluation of clinical outcomes (pain, appearance) over 2 years after hallux correction using a human, allogenic, bone screw or metal screw.
5 secondary outcomes
radiological (bony union)result of Hallux Valgus treatment
Time frame: 1 years
change in forefoot-American Orthopaedic Foot and Ankle Society (AOFAS)
Time frame: 2 years
Hallux-Valgus angle (HVA) change
Time frame: 2 years
gait analysis
Time frame: 2 years
Intermetatarsal angle (IMA) change
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. Due to sensitivity of Data
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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.
Andreas Kranzl, PhD contact
Florian Wenzel-Schwarz, MD principal investigator
Orthopädisches Spital Speising
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hallux Valgus Treatment with Shark Screw® and Hallux Valgus Treatment with metal screw in people with Hallux Valgus, run by Orthopedic Hospital Vienna Speising at 1 site 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 2 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Wenzel-Schwarz, MD (+43180182 ext. 3081, florian.wenzel@oss.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical result of Hallux Valgus treatment (time frame: 2 years). 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 2 Apr 2026.