Hallux ValgusNCT04145882
Efficacy of Additional Osteotomies to Correct Hallux Valgus
A study testing additional osteotomies in people with Hallux Valgus, run by Elsan at 4 sites in France.
Trial summary
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). 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?
- additional osteotomies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 515 participants
- Where
- 4 sitesFrance
- Study dates
- 11 Sep 2019to 11 Sep 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient older than 18 years.
- Informed consent
Who cannot join
- Associated lesser metatarsals surgery.
- Associated surgery on midfoot, hindfoot or ankle.
- Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
- Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
- Patient who declined the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinique Lille sud
Lesquin, 59810
Clinique du Parc Lyon
Lyon, 69006
Clinique Mégival
Saint-Aubin-sur-Scie, 76550
Clinique de l'Union
Saint-Jean, 31240
About this study
Official title: Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).
Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.
Read more
Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.
Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.
The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up
- Conditions
- Hallux Valgus
- Being tested
- additional osteotomies
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional osteotomiesProcedure or surgery
varisation osteotomy, supination osteotomy or both
| Study group | Role | What they receive |
|---|---|---|
| No additional osteotomy | Active comparator | Not described Receives: Procedure: additional osteotomies |
| varisation osteotomy addition | Experimental | Not described Receives: Procedure: additional osteotomies |
| supination osteotomy addition | Experimental | Not described Receives: Procedure: additional osteotomies |
| both (varisation + supination) osteotomies addition. | Experimental | Not described Receives: Procedure: additional osteotomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
on weight bearing X-Rays
Measured: 6 months
Secondary outcomes (5)
Recurrence of hallux valgus (HVA>20°).
Measured: 5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
Measured: 6 months
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
Measured: 5 years
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Measured: 6 months
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start11 Sep 2019
- Primary completion29 Jul 2021
- Study completion11 Sep 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145882
- Sponsor's protocol ID
- CPL-2019-HV
- Status last verified
- Feb 2024
- First submitted
- 29 Oct 2019
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04145882
- Acronym / sponsor ID
- CPL-2019-HV
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 515 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 11 Sep 2026 (estimated)
- First posted
- 31 Oct 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.
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).
Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.
Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.
Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.
The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No additional osteotomy | Active comparator | Procedure: additional osteotomies |
| varisation osteotomy addition | Experimental | Procedure: additional osteotomies |
| supination osteotomy addition | Experimental | Procedure: additional osteotomies |
| both (varisation + supination) osteotomies addition. | Experimental | Procedure: additional osteotomies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient older than 18 years.
- Informed consent
Key exclusion criteria (5 listed)
- Associated lesser metatarsals surgery.
- Associated surgery on midfoot, hindfoot or ankle.
- Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
- Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
- Patient who declined the study.
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 |
|---|---|---|
| additional osteotomiesvarisation osteotomy, supination osteotomy or both | Procedure or surgery | No additional osteotomy, both (varisation + supination) osteotomies addition., supination osteotomy addition, varisation osteotomy addition |
Primary outcome
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
Time frame: 6 months
on weight bearing X-Rays
5 secondary outcomes
Recurrence of hallux valgus (HVA>20°).
Time frame: 5 years
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Time frame: 6 months
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Time frame: 5 years
Patient satisfaction (Likert scale)
Time frame: 6 months
Patient satisfaction (Likert scale)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional osteotomies in people with Hallux Valgus, run by Elsan at 4 sites in France.
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 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
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?
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10° (time frame: 6 months). 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 29 Feb 2024.