Hallux Valgus and BunionNCT04288297
Minimally Invasive Distal Chevron in Comparison to the Reverdin-Isham Osteotomy for Hallux Valgus Correction
An observational study of Hallux Valgus and Bunion, run by Dr.Gerhard Kaufmann at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus and Bunion
- What is being tested?
- distal minimally invasive chevron osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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).
- Conditions
- Hallux Valgus and Bunion
- Being tested
- distal minimally invasive chevron osteotomy
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal minimally invasive chevron osteotomyProcedure or surgery
Also called austin, v-shaped osteotomy, percutaneous hallux valgus correction
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: distal minimally invasive chevron osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: change from preoperative to 24 months postoperative (as it is presented in literature)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Dec 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus and BunionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.Gerhard Kaufmann
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor-investigator, Dr.Gerhard Kaufmann, OFZ Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288297
- Sponsor's protocol ID
- 1062/2018
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24154993Brogan 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.
PubMed 25128969Jowett 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.
PubMed 28237566Lee 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.
PubMed 28476096Redfern D, Perera AM. Minimally invasive osteotomies. Foot Ankle Clin. 2014 Jun;19(2):181-9. doi: 10.1016/j.fcl.2014.02.002.
PubMed 24878408Brogan 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.
PubMed 27381179Crespo 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.
PubMed 28168637Maffulli 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.
PubMed 20710024
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04288297
- Acronym / sponsor ID
- 1062/2018
- Conditions
- Hallux Valgus and Bunion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr.Gerhard KaufmannUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| distal minimally invasive distal chevron | – | Procedure: distal minimally invasive chevron osteotomyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal minimally invasive chevron osteotomyAlso: austin, v-shaped osteotomy, percutaneous hallux valgus correctionWith 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. | Procedure or surgery | distal minimally invasive distal chevron |
Primary outcome
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.
2 secondary outcomes
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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Background: PubMed 24154993Vopat 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.
- Background: PubMed 25128969Brogan 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.
- Background: PubMed 28237566Jowett 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.
- Background: PubMed 28476096Lee 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.
- Background: PubMed 24878408Redfern D, Perera AM. Minimally invasive osteotomies. Foot Ankle Clin. 2014 Jun;19(2):181-9. doi: 10.1016/j.fcl.2014.02.002.
- Background: PubMed 27381179Brogan 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.
- Background: PubMed 28168637Crespo 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.
- Background: PubMed 20710024Maffulli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus and Bunion, run by Dr.Gerhard Kaufmann at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04288297, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.