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

NCT04288297 | Completed

• 1 other identifier: 1062/2018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hallux Valgus and Bunion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature

  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

  change from preoperative to 24 months postoperative (as it is presented in literature)

Study Arms (1)

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

Interventions

distal minimally invasive chevron osteotomy PROCEDURE

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.

Also known as: austin, v-shaped osteotomy, percutaneous hallux valgus correction

distal minimally invasive distal chevron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr.Gerhard Kaufmann: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Gerhard Kaufmann

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (8)

• 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.

  PMID: 24154993 BACKGROUND

• 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.

  PMID: 25128969 BACKGROUND

• 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.

  PMID: 28237566 BACKGROUND

• 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.

  PMID: 28476096 BACKGROUND

• Redfern D, Perera AM. Minimally invasive osteotomies. Foot Ankle Clin. 2014 Jun;19(2):181-9. doi: 10.1016/j.fcl.2014.02.002.

  PMID: 24878408 BACKGROUND

• 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.

  PMID: 27381179 BACKGROUND

• 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.

  PMID: 28168637 BACKGROUND

• 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.

  PMID: 20710024 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus; Bunion

Interventions

austin

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Gerhard Kaufmann, Principal investigator and Head of the Orthopaedic and Foot Center Innsbruck

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 28, 2020
• Study Start: December 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)