Clinical trial NCT04288297: Minimally Invasive Distal Chevron in Comparison to the Reverdin-Isham Osteotomy for Hallux Valgus Correction
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus and Bunion
Lead sponsor: OFZ Innsbruck
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2020-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: radiological outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature
timeFrame: change from preoperative to 24 months postoperative (as it is presented in literature)
Secondary outcomes:
measure: clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature
timeFrame: change from preoperative to 24 months postoperative (as it is presented in literature)
measure: clinical outcome after minimally invasive Chevron osteotomy in comparison to the minimally invasive Reverdin-Isham method presented in literature
timeFrame: change from preoperative to 24 months postoperative (as it is presented in literature)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Gerhard Kaufmann
state: Tirol
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Redfern D, Perera AM. Minimally invasive osteotomies. Foot Ankle Clin. 2014 Jun;19(2):181-9. doi: 10.1016/j.fcl.2014.02.002.
citation: 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.
citation: 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.
citation: 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.