Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486753
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
LSTR in Chevron Osteotomy
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Effect of Lateral Soft Tissue Release on Patient-Reported Outcomes and Hallux Valgus Angle Correction in Chevron Osteotomy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None