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NCT06486753 · ClinicalTrials.gov registry record · NA
LSTR in Chevron Osteotomy
A NA study of Bunion, sponsored by The Methodist Hospital Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06486753: Recruiting NA study of Bunion, sponsored by The Methodist Hospital Research Institute.
NCT06486753 is a NA study of Bunion that is actively recruiting participants, run by The Methodist Hospital Research Institute. The registered enrollment target is 200 participants, above the 133-participant average among 4 other Bunion trials with a reported enrollment target (50% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06486753, a NA study of Bunion, is actively recruiting participants, sponsored by The Methodist Hospital Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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 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).
Conditions Studied
Interventions
- PROCEDURE Chevron osteotomy bunion surgery with lateral soft tissue release
Study Locations (1)
Texas
- Houston Methodist Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2028-03-09 |
| Phase | NA |
What NCT06486753 shows while recruiting
NCT06486753 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 4 other Bunion trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Bunion appearing as the primary indexed condition, and to 1 intervention - of which Chevron osteotomy bunion surgery with lateral soft tissue release is the first listed.
NCT06486753 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06486753 about?
NCT06486753 is a clinical study titled "LSTR 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...
What is the current status of trial NCT06486753?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-06-24. Estimated completion is 2028-03-09.
What conditions does trial NCT06486753 study?
This clinical trial studies the following conditions: Bunion.
What interventions are being tested in trial NCT06486753?
The interventions under investigation include: Chevron osteotomy bunion surgery with lateral soft tissue release (PROCEDURE).
Who is sponsoring clinical trial NCT06486753?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06486753 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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