BunionNCT06486753
LSTR in Chevron Osteotomy
A study testing Chevron osteotomy bunion surgery with lateral soft tissue release in people with Bunion, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bunion
- What is being tested?
- Chevron osteotomy bunion surgery with lateral soft tissue release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 9 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18 years old
- Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
Who cannot join
- Under the age of 18
- Connective tissue disease
- Juvenile bunions
- Severe bunions
- Revision surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Research Institute
Houston, Texas, 77030
About this study
Official title: Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
The goal of this clinical trial is to determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:
How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.
Read more
Participants will:
- Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
- Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
- Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).
- Conditions
- Bunion
- Being tested
- Chevron osteotomy bunion surgery with lateral soft tissue release
- Medical subject headings
- Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chevron osteotomy bunion surgery with lateral soft tissue releaseProcedure or surgery
Lateral soft tissue release is often performed in hallux valgus correction, and there is preliminary evidence to suggest it may be useful in improving post-surgical outcomes for the Chevron osteotomy bunion surgery.
| Study group | Role | What they receive |
|---|---|---|
| Chevron osteotomy bunion surgery without LSTR | No intervention | Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery. |
| Chevron osteotomy bunion surgery with LSTR | Experimental | Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release. Receives: Procedure: Chevron osteotomy bunion surgery with lateral soft tissue release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux valgus alpha angle correction
Measured: Pre-surgery, 6 weeks post surgery
Secondary outcomes (3)
Intermetasarsal angle (IMA) degrees of correction
Measured: 3 months, 6 months, and 12 months post surgery
Recurrence of hallux valgus deformity
Measured: 3 months, 6 months, and 12 months post surgery
Complications following surgery
We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus).
Measured: 3 months, 6 months, and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start24 Jun 2021
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Varner, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486753
- Sponsor's protocol ID
- PRO00026261
- Status last verified
- Sep 2026
- First submitted
- 27 Jun 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
- ClinicalTrials.gov ID
- NCT06486753
- Acronym / sponsor ID
- PRO00026261
- Conditions
- Bunion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Dec 2028 (estimated)
- First posted
- 3 Jul 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 determine if performing a lateral soft tissue release during a Chevron osteotomy (or Akin osteotomy when appropriate) for bunions leads to better correction without added complications in 200 patients over the age of 18 years old with the capacity to consent and mild to moderate bunions that are determined to benefit from Chevron osteotomies by one of the IRB approved study physicians. The main questions it aims to answer are:
How does the addition of a lateral soft tissue release (LSTR) in a Chevron osteotomy bunion surgery affect hallux valgus alpha angle (HVA) correction? How does the addition of an LSTR in a Chevron osteotomy bunion surgery affect intermetatarsal angle (IMA) degrees of correction? Researchers will compare Chevron osteotomy bunion surgeries with and without LSTR to see if LSTRs lead to better correction without added complications.
Participants will:
- Be randomized to a control group where they receive a typical Chevron osteotomy bunion surgery or to the experimental group where they receive a Chevron osteotomy bunion surgery with an LSTR.
- Complete surveys preoperatively and at 3, 6, and 12 months after surgery.
- Receive routine x-rays pre and postoperatively to compare hallux valgus angle (HVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chevron osteotomy bunion surgery without LSTR | No intervention | –Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery. |
| Chevron osteotomy bunion surgery with LSTR | Experimental | Procedure: Chevron osteotomy bunion surgery with lateral soft tissue releaseParticipants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 18 years old
- Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
Key exclusion criteria (5 listed)
- Under the age of 18
- Connective tissue disease
- Juvenile bunions
- Severe bunions
- Revision surgery
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 |
|---|---|---|
| Chevron osteotomy bunion surgery with lateral soft tissue releaseLateral soft tissue release is often performed in hallux valgus correction, and there is preliminary evidence to suggest it may be useful in improving post-surgical outcomes for the Chevron osteotomy bunion surgery. | Procedure or surgery | Chevron osteotomy bunion surgery with LSTR |
Primary outcome
Hallux valgus alpha angle correction
Time frame: Pre-surgery, 6 weeks post surgery
3 secondary outcomes
Intermetasarsal angle (IMA) degrees of correction
Time frame: 3 months, 6 months, and 12 months post surgery
Recurrence of hallux valgus deformity
Time frame: 3 months, 6 months, and 12 months post surgery
Complications following surgery
Time frame: 3 months, 6 months, and 12 months post surgery
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 8 Sep 2026.
Related trials for Bunion
Not yet recruitingPhase 2
Postsurgical Analgesia After Unilateral Bunionectomy
Bunionectomy, Bunion
Not yet recruitingPhase 3
Phase 3 Bunionectomy Study
Postoperative Pain, Bunion
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Active, not recruitingPhase 3
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Postoperative Pain
Active, not recruiting
Early Weight-Bearing After the Lapiplasty Procedure
Hallux Valgus, Bunion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chevron osteotomy bunion surgery with lateral soft tissue release in people with Bunion, run by The Methodist Hospital Research Institute at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 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 United States. 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?
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?
Hallux valgus alpha angle correction (time frame: Pre-surgery, 6 weeks post surgery). 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 8 Sep 2026.