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NCT Number: NCT04288297

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gerhard Kaufmann

Innsbruck, Tyrol, 6020, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: austin, v-shaped osteotomy, percutaneous hallux valgus correction

Primary outcomes

  1. radiological outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature

    Time frame: change from preoperative to 24 months postoperative (as it is 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.

Secondary outcomes

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

    Time frame: change from preoperative to 24 months postoperative (as it is 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.

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

    Time frame: change from preoperative to 24 months postoperative (as it is 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.

Sponsors and collaborators

Lead sponsor

Dr.Gerhard Kaufmann

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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