Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2021-06-24
2028-03-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus
NCT04614675
Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction
NCT04823884
Prospective, Multi-Center Clinical Evaluation of the Open Wedge Osteotomy and Low Profile Plate & Screw (LPS) System Compared to the Proximal Chevron Osteotomy for the Treatment of Hallux Valgus With an Increased Intermetatarsal Angle
NCT01791634
Efficacy of Additional Osteotomies to Correct Hallux Valgus
NCT04145882
Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus
NCT04088214
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chevron osteotomy bunion surgery without LSTR
Participants randomized to this group will receive a standard Chevron osteotomy bunion surgery.
No interventions assigned to this group
Chevron osteotomy bunion surgery with LSTR
Participants randomized to this group will receive a Chevron osteotomy bunion surgery and a lateral soft tissue release.
Chevron osteotomy bunion surgery with lateral soft tissue release
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chevron osteotomy bunion surgery with lateral soft tissue release
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
Exclusion Criteria
* Connective tissue disease
* Juvenile bunions
* Severe bunions
* Revision surgery
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Methodist Hospital Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kevin Varner
Chairman of the Department of Orthopedics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Houston Methodist Research Institute
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRO00026261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.