Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

NCT04614675 | Unknown

• 1 other identifier: 2020-07-021B
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hallux Valgus

Keywords

Hallux valgus; Distal soft tissue procedure; Transarticular lateral release (TALR); Percutaneous lateral release (PCLR); Minimally invasive surgery

Outcome Measures

Primary Outcomes (31)

• 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 Outcomes (21)

• rate of osteonecrosis of first metatarsal head

  12-month

• rate of osteonecrosis of first metatarsal head

  24-month

• rate of osteonecrosis of first metatarsal head

  36-month

• rate of numbness of hallux

  12-month

• rate of numbness of hallux

  24-month

Study Arms (2)

Transarticular lateral release (TALR)

ACTIVE COMPARATOR

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

Percutaneous lateral release (PCLR)

ACTIVE COMPARATOR

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

Interventions

Distal soft tissue procedure with TALR PROCEDURE

TALR group: Transarticular lateral release as the distal soft tissue procedure

Transarticular lateral release (TALR)

Distal soft tissue procedure with PCLR PROCEDURE

PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure

Percutaneous lateral release (PCLR)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Related Publications (12)

• 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.

  PMID: 26152873 BACKGROUND

• 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.

  PMID: 25628283 BACKGROUND

• 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.

  PMID: 23632675 BACKGROUND

• 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.

  PMID: 24196470 BACKGROUND

• 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.

  PMID: 23917851 BACKGROUND

• 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.

  PMID: 31055210 BACKGROUND

• 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.

  PMID: 26920962 BACKGROUND

• 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.

  PMID: 26246258 BACKGROUND

• 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.

  PMID: 21733437 BACKGROUND

• 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.

  PMID: 23050706 BACKGROUND

• 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.

  PMID: 32456480 BACKGROUND

• 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.

  PMID: 19571086 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Chao-Ching Chiang, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Ching Chiang, MD

CONTACT

+886-2-28757557; 1966chiang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: November 4, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share