Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chevron osteotomy bunion surgery with lateral soft tissue release | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hallux valgus alpha angle correction | Pre-surgery, 6 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intermetasarsal angle (IMA) degrees of correction | 3 months, 6 months, and 12 months post surgery | |
| Recurrence of hallux valgus deformity | 3 months, 6 months, and 12 months post surgery | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haley M Goble, MHA | Contact | 713-441-3930 | hmgoble@houstonmethodist.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
Not provided
| ID | Term |
|---|---|
| D000071378 | Bunion |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Complications following surgery |
We will be looking at complications including possible metatarsal head avascular necrosis (AVN) and over correction (hallux varus). |
| 3 months, 6 months, and 12 months post surgery |