Actively Recruiting
Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
Led by The Methodist Hospital Research Institute · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of adding a lateral soft tissue release (LSTR) during Chevron osteotomy bunion surgery in adults over 18 years old with mild to moderate bunions. The study aims to find out if this addition improves correction of the hallux valgus alpha angle (HVA) and intermetatarsal angle (IMA) without causing extra complications. Two hundred patients will participate, and the trial is sponsored by The Methodist Hospital Research Institute. Participants will be randomly assigned to one of two groups: one will receive the standard Chevron osteotomy bunion surgery, and the other will have the same surgery plus a lateral soft tissue release. The study will compare outcomes between these two approaches. Surveys will be completed before surgery and at 3, 6, and 12 months after surgery to assess patient-reported results. During the study, routine X-rays will be taken before and after surgery to measure the hallux valgus angle and intermetatarsal angle corrections. Researchers will also monitor for recurrence of the bunion deformity and any complications at 3, 6, and 12 months after surgery. The main outcome measured is the correction of the hallux valgus alpha angle six weeks after surgery. Participation will last up to one year with regular follow-up visits.
CONDITIONS
Brief Title
LSTR in Chevron Osteotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over the age of 18 years old
- Have mild to moderate bunions that are determined to benefit from Chevron osteotomies
You will not qualify if you...
- Under the age of 18
- Connective tissue disease
- Juvenile bunions
- Severe bunions
- Revision surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate recovery period
Participants undergo Chevron osteotomy bunion surgery, with or without lateral soft tissue release, to correct hallux valgus.
1 surgery visit and approximately 6 post-operative visits
Duration - Up to 12 months post surgery
Participants are monitored for surgical outcomes including angle correction, deformity recurrence, and complications.
Visits at 6 weeks, 3 months, 6 months, and 12 months post surgery
Trial Site Locations
Total: 1 location
1
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley M Goble, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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