Hallux Valgushallux valgusNCT05880407
Pilot Study of Percutaneous Correction of Hallux Valgus
A study testing SERI osteotomy and percutaneous osteotomy according to Chevron in people with Hallux Valgus, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This is a pilot study with a randomized controlled design. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- SERI osteotomy and percutaneous osteotomy according to Chevron
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2022to 31 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
- HVA (hallux valgus angle): 20°-40°
- IMA (intermetatarsal angle): 10°-20°
Who cannot join
- Patients with instability of the first metatarsophalangeal joint
- Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
- patients requiring additional surgical procedures
- patients with severe vascular and neurological systemic pathologies
- systemic pathologies that may impair bone consolidation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Lisa Berti, MD, 051.63.66 ext. 571, lisa.berti@ior.it
About this study
Official title: Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
This is a pilot study with a randomized controlled design.
- Conditions
- Hallux Valgus
- Being tested
- SERI osteotomy, percutaneous osteotomy according to Chevron
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SERI osteotomyProcedure or surgery
Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire
percutaneous osteotomy according to ChevronProcedure or surgery
Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.
| Study group | Role | What they receive |
|---|---|---|
| standard treatment | Active comparator | SERI osteotomy Receives: Procedure: SERI osteotomy |
| experimental treatment | Experimental | percutaneous osteotomy according to Chevron Receives: Procedure: percutaneous osteotomy according to Chevron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score
pain visual analog assessment
Measured: baseline
Visual Analog Score
pain visual analog assessment
Measured: 1 year
Secondary outcomes (1)
American Orhtopaedic Foot and Ankle Society forefoot score
range of motion evaluation
Measured: baseline and aftef 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start22 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880407
- Sponsor's protocol ID
- hallux valgus
- Acronym
- hallux valgus
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
- ClinicalTrials.gov ID
- NCT05880407
- Acronym / sponsor ID
- hallux valgus / hallux valgus
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2023 (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 is a pilot study with a randomized controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment | Active comparator | Procedure: SERI osteotomySERI osteotomy |
| experimental treatment | Experimental | Procedure: percutaneous osteotomy according to Chevronpercutaneous osteotomy according to Chevron |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
- HVA (hallux valgus angle): 20°-40°
- IMA (intermetatarsal angle): 10°-20°
Key exclusion criteria (5 listed)
- Patients with instability of the first metatarsophalangeal joint
- Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
- patients requiring additional surgical procedures
- patients with severe vascular and neurological systemic pathologies
- systemic pathologies that may impair bone consolidation
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 |
|---|---|---|
| SERI osteotomyCorrection of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire | Procedure or surgery | standard treatment |
| percutaneous osteotomy according to ChevronCorrection of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal. | Procedure or surgery | experimental treatment |
Primary outcome
Visual Analog Score
Time frame: baseline
pain visual analog assessment
Visual Analog Score
Time frame: 1 year
pain visual analog assessment
1 secondary outcome
American Orhtopaedic Foot and Ankle Society forefoot score
Time frame: baseline and aftef 1 year
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 4 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SERI osteotomy and percutaneous osteotomy according to Chevron in people with Hallux Valgus, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 May 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 Italy. 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 Lisa Berti, MD (051.63.66 ext. 571, lisa.berti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score (time frame: baseline). The study lists 2 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 4 May 2026.