Minimally Invasive Distal Chevron in Comparison to the Reverdin-Isham Osteotomy for Hallux Valgus Correction

Midterm Results After Minimally Invasive Distal Chevron Osteotomy: Comparison of Our Results to the Minimally Invasive Reverdin-Isham Osteotomy From a Systematic Review of the Literature.

This study analyses the Reverdin Isham procedure, which is the most popular minimally invasive surgical hallux valgus correction method and the minimally invasive chevron osteotomy, representing the standard technique of open surgery. It is hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

Study Overview

• Status: Completed
• Conditions: Hallux Valgus and Bunion
• Intervention / Treatment: Procedure: distal minimally invasive chevron osteotomy

Detailed Description

Multiple different surgical techniques have been established for hallux valgus surgery so far, each technique with its unique advantages and limitations. The distal chevron method is widely accepted as a surgical method for correcting mild to moderate hallux valgus deformities. Numerous publications presenting the radiological outcome of this surgical technique and the clinical outcome by means of well established score systems have been published and make this technique, today's benchmark in hallux surgery.

Due to scarring and decreased range of motion of the greater toe joint after open surgery and increasing patients' demands several minimally invasive techniques have been brought to public in the last few years. These techniques claim minor soft tissue damage and reduced surgical time. The efficiency and stability of correction, as well as the clinical outcome of these techniques have been discussed controversially. However, most studies present data from minimally invasive surgery without specific differentiation of the type of surgery and in regard to the clinical and radiological outcome.

Recently a prospective randomized study comparing the open versus the minimally invasive chevron technique has been published presenting data with comparable clinical and radiological outcome.

Given the above-mentioned lack of evidence it was the aim of the study to compare the results of two different minimally invasive techniques. The investigators analyzed the Reverdin Isham procedure, which is known as the technique, that made minimally invasive hallux surgery popular and the minimally invasive chevron osteotomy. It was hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Gerhard Kaufmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A rseries of a cohort of hallux patients treated with the minimally invasive Chevron ostotomy with a Minimum follow-up of 24 months is analyzed retrospectively in regard to the clinical (different clinical scores) and radiological Outcome (radiographic Analysis of defined angles).

Description

Inclusion Criteria:

• patients after minimally invasive distal Chevron osteotomy for hallux valgus deformity with a Minimum follow up of 24 months
• patients with informed written consent for being analyzed
• patients, of whom radiographs are available from preoperative throughout the follow-up time of 24 months

Exclusion Criteria:

• patients under 18 years of age
• pregnant patients, or women below the age of 50 ys, of whom the pregnancy status is not clear
• patients with mental illness or patients, who cannot follow the required postoperative Treatment or controls
• patients, who refuse to participate
• patients, who are assigned to other clinical studies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

distal minimally invasive distal chevron; The investigators compare the results of a consecutive cohort of patients treated with the above mentioned technique in comparison to the results of patients treated with the minimally invasive Reverdin-Isham technique, presented in literature

Procedure: distal minimally invasive chevron osteotomy; With an electric motor-driven machine the resection of the medial eminence as well as a V-shaped osteotomy was performed in hallux valgus patients. Intraoperative fluoroscopy was used to identify the ideal osteotomy site and to control the Intervention. Fixation of the metatarsal head was achieved with a screw or with a K wire. Residual bone ridges were reamed and bone debris washed out.; Other Names: austin, v-shaped osteotomy, percutaneous hallux valgus correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature	radiographic (Hallux valgus angle, Intermetatarsal articular angle and distal metatarsal articular angle measured in grades) with the minimally invasive Chevron osteotomy is evaluated. Data is collected from a consecutive Patient cohort treated at the investigator´s Department. A cohort of more than 50 patients will be assessed.	change from preoperative to 24 months postoperative (as it is presented in literature)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature	clinical outcome (visual analogue scale- 10 Points maximum, 0 Points Minimum; higher score means worse outcome) with the minimally invasive Chevron osteotomy is evaluated.Data is collected from a consecutive Patient cohort treated at the investigator´s Department. A cohort of more than 50 patients will be assessed.	change from preoperative to 24 months postoperative (as it is presented in literature)
clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature	clinical outcome (AOFAS - American Orthopaedic Foot and Ankle Scale- 100 Points maximum, 0 Points Minimum; higher score means better outcome) with the minimally invasive Chevron osteotomy is evaluated.Data is collected from a consecutive Patient cohort treated at the investigator´s Department. A cohort of more than 50 patients will be assessed.	change from preoperative to 24 months postoperative (as it is presented in literature)

Collaborators and Investigators

• Sponsor: Dr.Gerhard Kaufmann
• Collaborators: Medical University Innsbruck

Publications and helpful links

General Publications

• Maffulli N, Longo UG, Marinozzi A, Denaro V. Hallux valgus: effectiveness and safety of minimally invasive surgery. A systematic review. Br Med Bull. 2011;97:149-67. doi: 10.1093/bmb/ldq027. Epub 2010 Aug 14.
• Vopat BG, Lareau CR, Johnson J, Reinert SE, DiGiovanni CW. Comparative study of scarf and extended chevron osteotomies for correction of hallux valgus. Foot Ankle Spec. 2013 Dec;6(6):409-16. doi: 10.1177/1938640013508431. Epub 2013 Oct 23.
• Brogan K, Voller T, Gee C, Borbely T, Palmer S. Third-generation minimally invasive correction of hallux valgus: technique and early outcomes. Int Orthop. 2014 Oct;38(10):2115-21. doi: 10.1007/s00264-014-2500-1. Epub 2014 Aug 17.
• Jowett CRJ, Bedi HS. Preliminary Results and Learning Curve of the Minimally Invasive Chevron Akin Operation for Hallux Valgus. J Foot Ankle Surg. 2017 May-Jun;56(3):445-452. doi: 10.1053/j.jfas.2017.01.002. Epub 2017 Feb 22.
• Lee M, Walsh J, Smith MM, Ling J, Wines A, Lam P. Hallux Valgus Correction Comparing Percutaneous Chevron/Akin (PECA) and Open Scarf/Akin Osteotomies. Foot Ankle Int. 2017 Aug;38(8):838-846. doi: 10.1177/1071100717704941. Epub 2017 May 5.
• Redfern D, Perera AM. Minimally invasive osteotomies. Foot Ankle Clin. 2014 Jun;19(2):181-9. doi: 10.1016/j.fcl.2014.02.002.
• Brogan K, Lindisfarne E, Akehurst H, Farook U, Shrier W, Palmer S. Minimally Invasive and Open Distal Chevron Osteotomy for Mild to Moderate Hallux Valgus. Foot Ankle Int. 2016 Nov;37(11):1197-1204. doi: 10.1177/1071100716656440. Epub 2016 Jul 4.
• Crespo Romero E, Penuela Candel R, Gomez Gomez S, Arias Arias A, Arcas Ordono A, Galvez Gonzalez J, Crespo Romero R. Percutaneous forefoot surgery for treatment of hallux valgus deformity: an intermediate prospective study. Musculoskelet Surg. 2017 Aug;101(2):167-172. doi: 10.1007/s12306-017-0464-1. Epub 2017 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: 1062/2018

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