Hallux ValgusNCT04823884
Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction
A study testing open distal chevron osteotomy and minimally invasive distal chevron osteotomy in people with Hallux Valgus and Minimally Invasive Surgical Procedures, run by Dr.Gerhard Kaufmann at 1 site in Austria.
Trial summary
By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus, Minimally Invasive Surgical Procedures
- What is being tested?
- open distal chevron osteotomy and minimally invasive distal chevron osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2021to 30 Jun 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients undergoing hallux valgus correction by means of a distal chevron osteotomy
Who cannot join
- surgery on the lesser rays of the same foot
- mental illness with impossibility to follow the postoperative protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction in Comparison to the Open Technique
By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.
Read the detailed description
The aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. Patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. Survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. Assessment of the clinical outcome measures in terms of the range of motion (ROM), Visual Analogue Scores (VAS) of pain, the American Orthopaedic Foot and Ankle Society (AOFAS) forefoot Score and a patient satisfaction score and a Life Quality score (SF 12) as well as the evaluation of the Charlson Comorbidity score is performed. It is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.
- Being tested
- open distal chevron osteotomy, minimally invasive distal chevron osteotomy
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open distal chevron osteotomyProcedure or surgery
Also called austin osteotomy
Through a 4-cm-long dorsomedial skin incision the V-shaped osteotomy with the apex 1-2 mm superior to the center of the metatarsal head is performed. The angle of the chevron is 60° to 90°. The direction of the osteotomy is angled toward the center of the third metatarsal head. After shifting the metatarsal head laterally, fixation is achieved by usage of one cannulated screw (3.0 mm or 2.5mm). Prominent bone ridges are resected with a saw. A distal soft tissue procedure is performed in every case through the same skin incision. The adductor hallucis tendon is detached from its insertion at the phalangeal bone and from the lateral border of the fibular sesamoid. The transverse intermetatarsal ligament is released and a T-shaped capsulotomy is performed to allow reposition of the sesamoids. Sesamoid position is controlled by sight. After closing of the medial capsula skin is closed with nylon sutures.
minimally invasive distal chevron osteotomyProcedure or surgery
The osteotomy is performed percutaneously through a dorsomedial incision of 3-5 mm. An electric motor-driven machine used for the osteotomy. To prevent overheating the reamer is frequently rinsed with sterile saline. The medial eminence is excised and the V-shaped osteotomy is performed. The apex of the osteotomy is identified by fluoroscopy and centered 1-2 mm superior to the center of the metatarsal head. The angle of the osteotomy amounts to 60-90 degrees as well. Bone debris is washed out with sterile saline. A lateral soft-tissue release is undertaken through a separate lateral incision of 3-5 mm. The distal fragment is shifted laterally and fixed with a canulated screw of 3.5mm. Residual bone ridges are reamed. Position of the metatarsal head and the K-wire is controlled by fluoroscopy. The skin is closed with a nylon sutures.
| Study group | Role | What they receive |
|---|---|---|
| open distal chevron osteotomy | Active comparator | Hallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy. Receives: Procedure: open distal chevron osteotomy |
| minimally invasive distal chevron osteotomy | Active comparator | Hallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy. Receives: Procedure: minimally invasive distal chevron osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome is assessed for both techniques with a clinical score to specific time points.
AOFAS Hallux etmatarsophalangeal -interphalangeal Scale [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Measured: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome is assessed for both techniques with a clinical score to specific time points.
Maryland Foot Score [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Measured: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome is assessed for both techniques with clinical a score to specific time points.
JSSF Hallux metatarsophalangeal -interphalangeal Scale [maximum 100 points, minimum 0 points - higher scores means better outcome]
Measured: Change of the score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical general situation is assessed for both techniques to specific time points by using the SF12 Life Quality Score [maximum 47 points, minimum 0 points - higher scores mean better clinical situation]
Measured: Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome and therefore the pain level is assessed for both techniques to specific time points by using the Visual Analogue Score for pain [0-10])
Measured: Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome is assessed for both techniques to specific time points by assessing the Range of motion (normal range 70-0-45 degrees)
Measured: Change of the range of motion and therefore the clinical outcome from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Clinical outcome and therefore changes of the foot circumference at the level of surgery is assessed for both techniques to specific time points by measuring the foot circumference at the level of surgery (measurement in centimeter).
Measured: Change of the foot circumference at the level of surgery from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.Gerhard Kaufmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.Gerhard Kaufmann, OFZ Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823884
- Sponsor's protocol ID
- 2021/1000
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Results After Minimally Invasive Chevron Osteotomy for Hallux Valgus Correction in Comparison to the Open Technique
- ClinicalTrials.gov ID
- NCT04823884
- Acronym / sponsor ID
- 2021/1000
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr.Gerhard KaufmannUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Apr 2021 (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.
By means of clinical satisfaction and clinical scores comparison of an open to a minimally invasive distal chevron osteotomy for correction of a hallux valgus deformity is performed.
Detailed description
The aim of this study is to evaluate shortterm clinical outcome after a minimally invasive chevron osteotomy technique for correction of hallux valgus deformity in comparison to the open distal chevron technique. Patients undergoing a distal chevron osteotomy for correction of a hallux valgus deformity are assigned to one of the two groups. Survey is taken preoperatively, after 2, 4, 6 and 12 weeks postoperatively. Assessment of the clinical outcome measures in terms of the range of motion (ROM), Visual Analogue Scores (VAS) of pain, the American Orthopaedic Foot and Ankle Society (AOFAS) forefoot Score and a patient satisfaction score and a Life Quality score (SF 12) as well as the evaluation of the Charlson Comorbidity score is performed. It is hypothesized, that clinical outcome with the minimally invasive distal chevron osteotomy is superior to the open technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open distal chevron osteotomy | Active comparator | Procedure: open distal chevron osteotomyHallux valgus correction is provided by using the traditional open distal v-shaped chevron osteotomy. |
| minimally invasive distal chevron osteotomy | Active comparator | Procedure: minimally invasive distal chevron osteotomyHallux valgus correction is provided by using a minimally invasive distal v-shaped chevron osteotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing hallux valgus correction by means of a distal chevron osteotomy
Key exclusion criteria (2 listed)
- surgery on the lesser rays of the same foot
- mental illness with impossibility to follow the postoperative protocol
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 |
|---|---|---|
| open distal chevron osteotomyAlso: austin osteotomyThrough a 4-cm-long dorsomedial skin incision the V-shaped osteotomy with the apex 1-2 mm superior to the center of the metatarsal head is performed. The angle of the chevron is 60° to 90°. The direction of the osteotomy is angled toward the center of the third metatarsal head. After shifting the metatarsal head laterally, fixation is achieved by usage of one cannulated screw (3.0 mm or 2.5mm). Prominent bone ridges are resected with a saw. A distal soft tissue procedure is performed in every case through the same skin incision. The adductor hallucis tendon is detached from its insertion at the phalangeal bone and from the lateral border of the fibular sesamoid. The transverse intermetatarsal ligament is released and a T-shaped capsulotomy is performed to allow reposition of the sesamoids. Sesamoid position is controlled by sight. After closing of the medial capsula skin is closed with nylon sutures. | Procedure or surgery | open distal chevron osteotomy |
| minimally invasive distal chevron osteotomyThe osteotomy is performed percutaneously through a dorsomedial incision of 3-5 mm. An electric motor-driven machine used for the osteotomy. To prevent overheating the reamer is frequently rinsed with sterile saline. The medial eminence is excised and the V-shaped osteotomy is performed. The apex of the osteotomy is identified by fluoroscopy and centered 1-2 mm superior to the center of the metatarsal head. The angle of the osteotomy amounts to 60-90 degrees as well. Bone debris is washed out with sterile saline. A lateral soft-tissue release is undertaken through a separate lateral incision of 3-5 mm. The distal fragment is shifted laterally and fixed with a canulated screw of 3.5mm. Residual bone ridges are reamed. Position of the metatarsal head and the K-wire is controlled by fluoroscopy. The skin is closed with a nylon sutures. | Procedure or surgery | minimally invasive distal chevron osteotomy |
Primary outcome
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques with a clinical score to specific time points. AOFAS Hallux etmatarsophalangeal -interphalangeal Scale [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques with a clinical score to specific time points. Maryland Foot Score [maximum 100 points, minimum 0 points - higher scores mean better outcome]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques with clinical a score to specific time points. JSSF Hallux metatarsophalangeal -interphalangeal Scale [maximum 100 points, minimum 0 points - higher scores means better outcome]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the SF 12 score from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical general situation is assessed for both techniques to specific time points by using the SF12 Life Quality Score [maximum 47 points, minimum 0 points - higher scores mean better clinical situation]
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the VAS from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome and therefore the pain level is assessed for both techniques to specific time points by using the Visual Analogue Score for pain [0-10])
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the range of motion and therefore the clinical outcome from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome is assessed for both techniques to specific time points by assessing the Range of motion (normal range 70-0-45 degrees)
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique .
Time frame: Change of the foot circumference at the level of surgery from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured
Clinical outcome and therefore changes of the foot circumference at the level of surgery is assessed for both techniques to specific time points by measuring the foot circumference at the level of surgery (measurement in centimeter).
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 7 Nov 2023.
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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?
A study testing open distal chevron osteotomy and minimally invasive distal chevron osteotomy in people with Hallux Valgus and Minimally Invasive Surgical Procedures, 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 1 inclusion and 2 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 7 Nov 2023. 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?
Clinical outcome after correction of hallux valgus deformity within the first three months after surgery: a comparison of the minimally invasive versus the open distal chevron osteotomy technique . (time frame: Change of the scores from preoperative to postoperative at 2 weeks, 4 weeks, 6 and 12 weeks is measured). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.