Hallux Valgus and BunionHAV-EHL-MISNCT06243471
Hallux Abductus Valgus and Extensor Hallux Longus; Treatment by MIS Surgery
An observational study of Hallux Valgus and Bunion, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial summary
The goal of this clinical trial is to investigate the relationship between Hallux Abductus Valgus (HAV) and the hyperextension of the Extensor Hallucis Longus (EHL) tendon. The study aims to understand the efficacy of MIS surgery in treating foot deformities like HAV and to evaluate the impact of EHL tendon… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- Minimally invasive procedures for the Hallux Abductus Valgus. and Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 12 Feb 2025
- How long will I take part?
- 6 Months
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this project is men and women between 20 and 90 years old with hallux abductus valgus and the first toe in hyperextension on one or both feet. The subjects in the sample will be patients undergoing surgery in private clinics who come for consultation at the time of the study. The method to select the sample is non-probabilistic due to the inclusion of volunteers.
Who may be able to join
- Pain in the metatarsophalangeal joint of the big toe caused by HAV.
- Moderate and severe Hallux Abductus Valgus.
- Incorrect metatarsal shape of the 2nd, 3rd and 4th rays due to HAV.
- Be between 20 and 90 years old.
- Patients with no osteoarthritis.
Who cannot join
- Patients who have previously undergone surgery for Hallux Abductus Valgus.
- Pregnant patients.
- Patients with coagulopathies, diabetes or risk disease (ASA lll, ASA lV).
- Patients with high-risk pharmacological treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Hallux Abductus Valgus and Extensor Hallux Longus: Relationship Between Them, Preoperative and Postoperative Assessment, Pressure Platform and Treatment by MIS Surgery"
The goal of this clinical trial is to investigate the relationship between Hallux Abductus Valgus (HAV) and the hyperextension of the Extensor Hallucis Longus (EHL) tendon. The study aims to understand the efficacy of MIS surgery in treating foot deformities like HAV and to evaluate the impact of EHL tendon hyperextension on this condition.
The main questions this study aims to answer are:
Read more
- How does the hyperextension of the EHL tendon correlate with the presence and severity of HAV?
- What is the effectiveness of MIS surgery in correcting HAV deformities and addressing issues related to EHL tendon hyperextension? Participants in this study will undergo pre-surgical evaluation to assess the severity of HAV and measure the extent of EHL tendon hyperextension using pressure platform analysis and other relevant clinical measures. During the MIS surgery, participants will receive treatment targeted at correcting HAV, possibly involving partial tenotomy.
If there is a comparison group: Researchers will compare individuals who undergo MIS surgery for HAV correction with a control group not receiving this intervention. The comparison aims to assess the effects of MIS surgery on both HAV correction and the relationship between EHL tendon hyperextension and the deformity.
This study endeavors to shed light on the relationship between HAV and EHL tendon hyperextension, the effectiveness of MIS surgery in addressing these issues, and potentially pave the way for improved surgical techniques in treating foot pathologies.
Read the detailed description
Main Objective: To analyze the effectiveness of incomplete zig-zag tenotomy of the EHL combined with minimally invasive foot surgery for the correction of moderate and severe hallux abducts valgus (HAV).
Secondary Objectives:
Compare pre-surgical and post-surgical plantar pressure changes. Determine American Orthopaedic Foot \& Ankle Society Scale (AOFAS scale) values pre-surgery and post-surgery.
Compare the improvement in post-surgical results of angles: HAV, Intermetatarsal Angle (AIM),Proximal Articular Set Angle (PASA),Distal Articular Set Angle(DASA), and the metatarsophalangeal angle of the first ray (lateral projection).
Materials and Methods: The chosen study design is an experimental, controlled, non-randomized, longitudinal, analytical, and prospective study. Subjects meeting the selection criteria will be non-randomly assigned to two different groups: the "Minimally Invasive Surgery Group with Zig-zag EHL Tenotomy" and the "Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy." After surgery, a follow-up with radiological control will be performed, where post-surgical angles will be measured and plantar pressures will be evaluated.
Results: The investigators expect to achieve effective and safe lengthening of the long hallux extensor in all patients with HAV and hyperextension of the first toe.
Conclusions: The study results will indicate that zig-zag tenotomy of the long hallux extensor is a safe, effective, and rapid technique.
- Conditions
- Hallux Valgus and Bunion
- Being tested
- Minimally invasive procedures for the Hallux Abductus Valgus., Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
- Keywords
- minimal incision surgery, Tenotomy, Extensor hallucis longus, Hallux Abducts Valgus
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive procedures for the Hallux Abductus Valgus.Procedure or surgery
Minimally invasive procedures for the Hallux Abductus Valgus
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.Procedure or surgery
Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Minimally Invasive Surgery Group with Zigzag EHL Tenotomy Receives: Procedure: Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus. | |
| Group 2 | Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy Receives: Procedure: Minimally invasive procedures for the Hallux Abductus Valgus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic
Flat Panel is a direct digitization radiography system that provides us with the image in two seconds. The investigators will perform dorso-plantar and lateral oblique radiographs of the patients' feet.
Measured: Pre-surgery, 2 months, 6months
Secondary outcomes (2)
Pressure platform
It is a tool that allows us to know the distribution of pressures on the sole of the foot, both statically and dynamically. It offers a range of colors in the patient's footprint according to the baropressure captured. It will help us determine the change in pre-surgical and post-surgical plantar pressures.
Measured: Pre-surgery, 2 months, 6months
American Orthopedic Foot and Ankle Society
This questionnaire incorporates subjective and objective factors that are scored using a numerical scale and describe variables of function, alignment and pain. The score ranges from 0 to 100 depending on the degree of limitation of the patient.
Measured: Pre-surgery, 2 months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus and BunionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Ferrer-Torregrosa, Dr., Study director, Fundación Universidad Católica de Valencia San Vicente Mártir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243471
- Sponsor's protocol ID
- UCV/2022-2023/035
- Acronym
- HAV-EHL-MIS
- Status last verified
- Jul 2024
- First submitted
- 19 Jan 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marijuschkin I, Souza ML, Diaz JLG, Carvalho P. Percutaneous Hallux Valgus: An Algorithm for the Surgical Treatment. Rev Bras Ortop (Sao Paulo). 2021 Aug;56(4):504-512. doi: 10.1055/s-0040-1721367. Epub 2021 Aug 30.
PubMed 34483396Restuccia G, Lippi A, Sacchetti F, Citarelli C, Casella F, Benifei M. Percutaneous Hallux Valgus Correction: Modified Reverdin-Isham Osteotomy, Preliminary Results. Surg Technol Int. 2017 Dec 22;31:263-266.
PubMed 29310149Bauer T, Biau D, Lortat-Jacob A, Hardy P. Percutaneous hallux valgus correction using the Reverdin-Isham osteotomy. Orthop Traumatol Surg Res. 2010 Jun;96(4):407-16. doi: 10.1016/j.otsr.2010.01.007. Epub 2010 May 20.
PubMed 20488776Botezatu I, Marinescu R, Laptoiu D. Minimally invasive-percutaneous surgery - recent developments of the foot surgery techniques. J Med Life. 2015;8 Spec Issue(Spec Issue):87-93.
PubMed 26361518Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
PubMed 20710024Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.
PubMed 27919259Lu J, Zhao H, Liang X, Ma Q. Comparison of Minimally Invasive and Traditionally Open Surgeries in Correction of Hallux Valgus: A Meta-Analysis. J Foot Ankle Surg. 2020 Jul-Aug;59(4):801-806. doi: 10.1053/j.jfas.2019.03.021.
PubMed 32600562Bia A, Guerra-Pinto F, Pereira BS, Corte-Real N, Oliva XM. Percutaneous Osteotomies in Hallux Valgus: A Systematic Review. J Foot Ankle Surg. 2018 Jan-Feb;57(1):123-130. doi: 10.1053/j.jfas.2017.06.027. Epub 2017 Sep 1.
PubMed 28870735Sanchis-Soria V, Ferrer-Torregrosa J, Marti-Martinez LM, Carratala-Villarroya G, Vicente-Mampel J, Lorca-Gutierrez R. Multimodal evaluation of partial zig-zag tenotomy of the extensor hallucis longus in minimally invasive hallux valgus surgery: a randomized trial. J Orthop Surg Res. 2025 Nov 28;21(1):3. doi: 10.1186/s13018-025-06456-x.
PubMed 41316331
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Hallux Abductus Valgus and Extensor Hallux Longus: Relationship Between Them, Preoperative and Postoperative Assessment, Pressure Platform and Treatment by MIS Surgery"
- ClinicalTrials.gov ID
- NCT06243471
- Acronym / sponsor ID
- HAV-EHL-MIS / UCV/2022-2023/035
- Conditions
- Hallux Valgus and Bunion
- Keywords
- minimal incision surgery, Tenotomy, Extensor hallucis longus, Hallux Abducts Valgus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 6 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 investigate the relationship between Hallux Abductus Valgus (HAV) and the hyperextension of the Extensor Hallucis Longus (EHL) tendon. The study aims to understand the efficacy of MIS surgery in treating foot deformities like HAV and to evaluate the impact of EHL tendon hyperextension on this condition.
The main questions this study aims to answer are:
- How does the hyperextension of the EHL tendon correlate with the presence and severity of HAV?
- What is the effectiveness of MIS surgery in correcting HAV deformities and addressing issues related to EHL tendon hyperextension? Participants in this study will undergo pre-surgical evaluation to assess the severity of HAV and measure the extent of EHL tendon hyperextension using pressure platform analysis and other relevant clinical measures. During the MIS surgery, participants will receive treatment targeted at correcting HAV, possibly involving partial tenotomy.
If there is a comparison group: Researchers will compare individuals who undergo MIS surgery for HAV correction with a control group not receiving this intervention. The comparison aims to assess the effects of MIS surgery on both HAV correction and the relationship between EHL tendon hyperextension and the deformity.
This study endeavors to shed light on the relationship between HAV and EHL tendon hyperextension, the effectiveness of MIS surgery in addressing these issues, and potentially pave the way for improved surgical techniques in treating foot pathologies.
Detailed description
Main Objective: To analyze the effectiveness of incomplete zig-zag tenotomy of the EHL combined with minimally invasive foot surgery for the correction of moderate and severe hallux abducts valgus (HAV).
Secondary Objectives:
Compare pre-surgical and post-surgical plantar pressure changes. Determine American Orthopaedic Foot \& Ankle Society Scale (AOFAS scale) values pre-surgery and post-surgery.
Compare the improvement in post-surgical results of angles: HAV, Intermetatarsal Angle (AIM),Proximal Articular Set Angle (PASA),Distal Articular Set Angle(DASA), and the metatarsophalangeal angle of the first ray (lateral projection).
Materials and Methods: The chosen study design is an experimental, controlled, non-randomized, longitudinal, analytical, and prospective study. Subjects meeting the selection criteria will be non-randomly assigned to two different groups: the "Minimally Invasive Surgery Group with Zig-zag EHL Tenotomy" and the "Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy." After surgery, a follow-up with radiological control will be performed, where post-surgical angles will be measured and plantar pressures will be evaluated.
Results: The investigators expect to achieve effective and safe lengthening of the long hallux extensor in all patients with HAV and hyperextension of the first toe.
Conclusions: The study results will indicate that zig-zag tenotomy of the long hallux extensor is a safe, effective, and rapid technique.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.Minimally Invasive Surgery Group with Zigzag EHL Tenotomy |
| Group 2 | – | Procedure: Minimally invasive procedures for the Hallux Abductus Valgus.Minimally Invasive Surgery Group without Zig-zag EHL Tenotomy |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this project is men and women between 20 and 90 years old with hallux abductus valgus and the first toe in hyperextension on one or both feet. The subjects in the sample will be patients undergoing surgery in private clinics who come for consultation at the time of the study. The method to select the sample is non-probabilistic due to the inclusion of volunteers.
Key inclusion criteria (5 listed)
- Pain in the metatarsophalangeal joint of the big toe caused by HAV.
- Moderate and severe Hallux Abductus Valgus.
- Incorrect metatarsal shape of the 2nd, 3rd and 4th rays due to HAV.
- Be between 20 and 90 years old.
- Patients with no osteoarthritis.
Key exclusion criteria (4 listed)
- Patients who have previously undergone surgery for Hallux Abductus Valgus.
- Pregnant patients.
- Patients with coagulopathies, diabetes or risk disease (ASA lll, ASA lV).
- Patients with high-risk pharmacological treatments.
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 |
|---|---|---|
| Minimally invasive procedures for the Hallux Abductus Valgus.Minimally invasive procedures for the Hallux Abductus Valgus | Procedure or surgery | Group 2 |
| Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus.Minimally invasive procedures for the Hallux Abductus Valgus and a zig-zag tenotomy for the extensus hallux longus. | Procedure or surgery | Group 1 |
Primary outcome
Radiographic
Time frame: Pre-surgery, 2 months, 6months
Flat Panel is a direct digitization radiography system that provides us with the image in two seconds. The investigators will perform dorso-plantar and lateral oblique radiographs of the patients' feet.
2 secondary outcomes
Pressure platform
Time frame: Pre-surgery, 2 months, 6months
American Orthopedic Foot and Ankle Society
Time frame: Pre-surgery, 2 months, 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Results publication: PubMed 34483396Marijuschkin I, Souza ML, Diaz JLG, Carvalho P. Percutaneous Hallux Valgus: An Algorithm for the Surgical Treatment. Rev Bras Ortop (Sao Paulo). 2021 Aug;56(4):504-512. doi: 10.1055/s-0040-1721367. Epub 2021 Aug 30.
- Results publication: PubMed 29310149Restuccia G, Lippi A, Sacchetti F, Citarelli C, Casella F, Benifei M. Percutaneous Hallux Valgus Correction: Modified Reverdin-Isham Osteotomy, Preliminary Results. Surg Technol Int. 2017 Dec 22;31:263-266.
- Results publication: PubMed 20488776Bauer T, Biau D, Lortat-Jacob A, Hardy P. Percutaneous hallux valgus correction using the Reverdin-Isham osteotomy. Orthop Traumatol Surg Res. 2010 Jun;96(4):407-16. doi: 10.1016/j.otsr.2010.01.007. Epub 2010 May 20.
- Results publication: PubMed 26361518Botezatu I, Marinescu R, Laptoiu D. Minimally invasive-percutaneous surgery - recent developments of the foot surgery techniques. J Med Life. 2015;8 Spec Issue(Spec Issue):87-93.
- Results publication: PubMed 20710024Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
- Results publication: PubMed 27919259Biz C, Fosser M, Dalmau-Pastor M, Corradin M, Roda MG, Aldegheri R, Ruggieri P. Functional and radiographic outcomes of hallux valgus correction by mini-invasive surgery with Reverdin-Isham and Akin percutaneous osteotomies: a longitudinal prospective study with a 48-month follow-up. J Orthop Surg Res. 2016 Dec 5;11(1):157. doi: 10.1186/s13018-016-0491-x.
- Results publication: PubMed 32600562Lu J, Zhao H, Liang X, Ma Q. Comparison of Minimally Invasive and Traditionally Open Surgeries in Correction of Hallux Valgus: A Meta-Analysis. J Foot Ankle Surg. 2020 Jul-Aug;59(4):801-806. doi: 10.1053/j.jfas.2019.03.021.
- Results publication: PubMed 28870735Bia A, Guerra-Pinto F, Pereira BS, Corte-Real N, Oliva XM. Percutaneous Osteotomies in Hallux Valgus: A Systematic Review. J Foot Ankle Surg. 2018 Jan-Feb;57(1):123-130. doi: 10.1053/j.jfas.2017.06.027. Epub 2017 Sep 1.
- Derived from this study: PubMed 41316331Sanchis-Soria V, Ferrer-Torregrosa J, Marti-Martinez LM, Carratala-Villarroya G, Vicente-Mampel J, Lorca-Gutierrez R. Multimodal evaluation of partial zig-zag tenotomy of the extensor hallucis longus in minimally invasive hallux valgus surgery: a randomized trial. J Orthop Surg Res. 2025 Nov 28;21(1):3. doi: 10.1186/s13018-025-06456-x.
- Individual participant dataSharing planned: No
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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.
Javier Ferrer-Torregrosa, Dr. study director
Fundación Universidad Católica de Valencia San Vicente Mártir
1 site 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 and Bunion, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 17 Feb 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic (time frame: Pre-surgery, 2 months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243471, which also lists 9 linked publications.
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 17 Feb 2025.