Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 140
- Primary Endpoint
- hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Study Overview
Brief Summary
background Hallux valgus (HV) is a common forefoot disorder in need of surgical intervention after failed conservative treatment. Surgical treatment of HV generally includes different kinds of osteotomy in combination with different distal soft tissue procedures (DSTP). Commonly used DSTP are open first-web lateral release, transarticular lateral release (TALR), and percutaneous lateral release (PCLR). In some studies, TALR showed similar surgical outcomes with open first-web space lateral release. Besides, PCLR has been described with satisfactory outcomes. TALR and PCLR are gaining popularity due to their less invasive approach and potential in combination with a distal metatarsal Chevron osteotomy (DMCO). Currently, there is no study comparing the surgical results between TALR and PCLR for surgical reconstruction of HV.
Aim The aim of this prospective randomized trial is to compare the surgical outcomes of TALR versus PCLR, both in combination of DMCO, for the treatment of HV. Our hypothesis is that TALR would achieve a better surgical outcomes than PCLR.
Detailed Description
This study will be conducted from January, 2021 to December, 2024. A total of 140 participants are included with 70 participants in each group. Participants are allocated to TALR or PCLR group before index surgery according to a computer-generated randomization list.
For all patients, after regional nerve block and adequate sedation, intraoperative stress test is performed for flexibility of first metatarsophalangeal joint (MTPJ).6 The test is confirmed with dorsoplantar fluoroscopy. Only the cases with negative results (passive correction is not possible) are included. Then, a medial incision of 2.5-cm is made at distal metatarsal head and a reverse L-shaped medial capsulotomy is made followed by TALR or PCLR.
After TALR or PCLR, medial bunionectomy is performed. DMCO is made with the apex at distal metatarsal neck and angle of 60 to 90 degrees. The metatarsal head is laterally moved and fixed with one or 2 oblique headless compression screws.
Postoperative followup The patients are followed up at two weeks for removal of stitches, then 1-month, 2-month, 3-month, 6-months, 1-year, and annually after 1 year for radiographic , functional assessments, and evaluation of complications.
Power analysis for patient number With the assumption of mean HVA are 10 degrees for TALR group and 15 degrees for PCLR group at final followup, and a standard deviation of 8 degrees for both groups, the calculated effect size d is 0.625. In order to achieve the α error probability of 0.05 and power of 0.95, 68 participants in each group are necessary with a total of 136 participants in this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age equal or greater than 20 years
- •Hallux valgus angle (HVA) equal or greater than 20 degrees
- •Persistent symptoms after failed conservative treatment
- •Receiving DMCO for HV
Exclusion Criteria
- •Underlying rheumatoid or other inflammatory arthritis
- •Hallux rigidus
- •Recurrent hallux valgus after previous surgery
- •First tarsometatarsal hypermobility
- •A positive intraoperative stress test for lateral soft tissue release
Outcomes
Primary Outcomes
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time Frame: postoperative 36-months
functional score, 0-100, the higher the better
hallux valgus angle (HVA)(degrees)
Time Frame: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time Frame: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
sesamoid position
Time Frame: postoperative 36-month
weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham
visual analogue scale (VAS) for pain
Time Frame: postoperative 36-months
pain score, (0-10, the lower the better)
Secondary Outcomes
- rate of recurrent hallux valgus(36-month)
- rate of osteonecrosis of first metatarsal head(36-month)
- rate of hallux varus(36-month)
- rate of infection(36-month)
- rate of reoperations(36-month)
- rate of numbness of hallux(36-month)
- rate of first MTPJ arthritis(36-month)