Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: Distal soft tissue procedure with TALR; Procedure: Distal soft tissue procedure with 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.

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

1. Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon.
2. If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chao-Ching Chiang, MD; Phone Number: 140 +886-2-28757557; Email: 1966chiang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transarticular lateral release (TALR); 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; TALR group: Transarticular lateral release as the distal soft tissue procedure
Active Comparator: Percutaneous lateral release (PCLR); 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; PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Chao-Ching Chiang, MD, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• Wagner E, Ortiz C, Figueroa F, Vela O, Wagner P, Gould JS. Role of a Limited Transarticular Release in Severe Hallux Valgus Correction. Foot Ankle Int. 2015 Nov;36(11):1322-9. doi: 10.1177/1071100715593082. Epub 2015 Jul 7.
• Lee KB, Cho NY, Park HW, Seon JK, Lee SH. A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):202-7. doi: 10.1302/0301-620X.97B2.34449.
• Park CH, Jang JH, Lee SH, Lee WC. A comparison of proximal and distal chevron osteotomy for the correction of moderate hallux valgus deformity. Bone Joint J. 2013 May;95-B(5):649-56. doi: 10.1302/0301-620X.95B5.30181.
• Park YB, Lee KB, Kim SK, Seon JK, Lee JY. Comparison of distal soft-tissue procedures combined with a distal chevron osteotomy for moderate to severe hallux valgus: first web-space versus transarticular approach. J Bone Joint Surg Am. 2013 Nov 6;95(21):e158. doi: 10.2106/JBJS.L.01017.
• Ahn JY, Lee HS, Chun H, Kim JS, Seo DK, Choi YR, Kim SW. Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction. Int Orthop. 2013 Sep;37(9):1781-7. doi: 10.1007/s00264-013-2023-1. Epub 2013 Aug 6.
• de Las Heras-Romero J, Lledo-Alvarez AM, Andres-Grau J, Picazo-Marin F, Moreno-Sanchez JF, Hernandez-Torralba M. A new minimally extended distal Chevron osteotomy (MEDCO) with percutaneous soft tissue release (PSTR) for treatment of moderate hallux valgus. Foot (Edinb). 2019 Sep;40:27-33. doi: 10.1016/j.foot.2019.04.001. Epub 2019 Apr 4.
• Lucas y Hernandez J, Golano P, Roshan-Zamir S, Darcel V, Chauveaux D, Laffenetre O. Treatment of moderate hallux valgus by percutaneous, extra-articular reverse-L Chevron (PERC) osteotomy. Bone Joint J. 2016 Mar;98-B(3):365-73. doi: 10.1302/0301-620X.98B3.35666.
• Bock P, Kluger R, Kristen KH, Mittlbock M, Schuh R, Trnka HJ. The Scarf Osteotomy with Minimally Invasive Lateral Release for Treatment of Hallux Valgus Deformity: Intermediate and Long-Term Results. J Bone Joint Surg Am. 2015 Aug 5;97(15):1238-45. doi: 10.2106/JBJS.N.00971.
• Kim HN, Suh DH, Hwang PS, Yu SO, Park YW. Role of intraoperative varus stress test for lateral soft tissue release during chevron bunion procedure. Foot Ankle Int. 2011 Apr;32(4):362-7. doi: 10.3113/FAI.2011.0362.
• Choi YR, Lee HS, Jeong JJ, Kim SW, Jeon IH, Lee DH, Lee WC. Hallux valgus correction using transarticular lateral release with distal chevron osteotomy. Foot Ankle Int. 2012 Oct;33(10):838-43. doi: 10.3113/FAI.2012.0838.
• Dalmau-Pastor M, Malagelada F, Cordier G, Del Vecchio JJ, Ghioldi ME, Vega J. Anatomical Study of Minimally Invasive Lateral Release Techniques for Hallux Valgus Treatment. Foot Ankle Int. 2020 Aug;41(8):984-992. doi: 10.1177/1071100720920863. Epub 2020 May 26.
• Okuda R, Kinoshita M, Yasuda T, Jotoku T, Kitano N, Shima H. Postoperative incomplete reduction of the sesamoids as a risk factor for recurrence of hallux valgus. J Bone Joint Surg Am. 2009 Jul;91(7):1637-45. doi: 10.2106/JBJS.H.00796.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Minimally invasive surgery; Hallux valgus; Distal soft tissue procedure; Transarticular lateral release (TALR); Percutaneous lateral release (PCLR)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: 2020-07-021B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No