Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

Study Overview
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Brief Summary
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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
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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. Statistical analysis In the comparisons between TALR and PCLR groups, the independent two samples t-test and the Mann-Whitney test are performed for normal and non-normal distributed data respectively, and the Fisher's exact test is performed for categorical data. P-values less than 0.05 is considered to be statistical significant. The statistical analyses are performed by using SPSS 25.0 statistics software (SPSS Inc, Chicago, USA). Clinical relevance Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon. If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.

Official Title
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Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-

Conditions
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Hallux Valgus

Intervention / Treatment
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* Procedure: Distal soft tissue procedure with TALR
* Procedure: Distal soft tissue procedure with PCLR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transarticular lateral release (TALR)<br>TALR The first toe is pulled distally for access into the lateral aspect of first MTPJ. A No.15 beaver blade is advanced from the medial incision laterally to divide the lateral capsule vertically and adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction. | Procedure: Distal soft tissue procedure with TALR<br>* TALR group: Transarticular lateral release as the distal soft tissue procedure<br>|
| Active Comparator: Percutaneous lateral release (PCLR)<br>PCLR A 0.5 cm stab wound is made at lateral aspect of first MTPJ. A No. 15 beaver blade is advanced into the lateral side of MTPJ with a quarter of the blade inside the joint and verified with fluoroscope. The blade is turned laterally to face the adductor hallucis tendon. The adductor tendon is divided with lateral movement of the blade and varus manipulation of proximal phalanx. A click is heard as adequate release of adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction. | Procedure: Distal soft tissue procedure with PCLR<br>* PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 1-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 2-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 3-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 6-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 12-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 24-month | 
| hallux valgus angle (HVA)(degrees) | weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal | postoperative 36-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 1-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 2-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 3-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 6-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 12-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 24-month | 
| intermetatarsal angle (IMA) 1-2 (degrees) | weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal | postoperative 36-month | 
| sesamoid position | 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 | postoperative 1-month | 
| sesamoid position | 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 | postoperative 2-month | 
| sesamoid position | 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 | postoperative 3-month | 
| sesamoid position | 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 | postoperative 6-month | 
| sesamoid position | 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 | postoperative 12-month | 
| sesamoid position | 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 | postoperative 24-month | 
| sesamoid position | 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 | postoperative 36-month | 
| visual analogue scale (VAS) for pain | pain score, (0-10, the lower the better) | postoperative 3-months | 
| visual analogue scale (VAS) for pain | pain score, (0-10, the lower the better) | postoperative 6-months | 
| visual analogue scale (VAS) for pain | pain score, (0-10, the lower the better) | postoperative 12-months | 
| visual analogue scale (VAS) for pain | pain score, (0-10, the lower the better) | postoperative 24-months | 
| visual analogue scale (VAS) for pain | pain score, (0-10, the lower the better) | postoperative 36-months | 
| hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) | functional score, 0-100, the higher the better | postoperative 3-months | 
| hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) | functional score, 0-100, the higher the better | postoperative 6-months | 
| hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) | functional score, 0-100, the higher the better | postoperative 12-months | 
| hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) | functional score, 0-100, the higher the better | postoperative 24-months | 
| hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) | functional score, 0-100, the higher the better | postoperative 36-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of osteonecrosis of first metatarsal head | postoperative complications | 12-month | 
| rate of osteonecrosis of first metatarsal head | postoperative complications | 24-month | 
| rate of osteonecrosis of first metatarsal head | postoperative complications | 36-month | 
| rate of numbness of hallux | postoperative complication | 12-month | 
| rate of numbness of hallux | postoperative complication | 24-month | 
| rate of numbness of hallux | postoperative complication | 36-month | 
| rate of infection | postoperative complication | 12-month | 
| rate of infection | postoperative complication | 24-month | 
| rate of infection | postoperative complication | 36-month | 
| rate of first MTPJ arthritis | postoperative complication | 12-month | 
| rate of first MTPJ arthritis | postoperative complication | 24-month | 
| rate of first MTPJ arthritis | postoperative complication | 36-month | 
| rate of recurrent hallux valgus | postoperative complication, hallux valgus angle equal or greater than 20 degrees | 12-month | 
| rate of recurrent hallux valgus | postoperative complication, hallux valgus angle equal or greater than 20 degrees | 24-month | 
| rate of recurrent hallux valgus | postoperative complication, hallux valgus angle equal or greater than 20 degrees | 36-month | 
| rate of hallux varus | postoperative complication | 12-month | 
| rate of hallux varus | postoperative complication | 24-month | 
| rate of hallux varus | postoperative complication | 36-month | 
| rate of reoperations | postoperative complication | 12-month | 
| rate of reoperations | postoperative complication | 24-month | 
| rate of reoperations | postoperative complication | 36-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hallux valgus, Distal soft tissue procedure, Transarticular lateral release (TALR), Percutaneous lateral release (PCLR), Minimally invasive surgery