Hallux Valgus DeformityNCT06625229
Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
An observational study of Hallux Valgus Deformity and Hallux Valgus (Bunion) Resection, run by Orthopaedic and Arthritis Specialist Centre at 1 site in Australia.
Trial summary
The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are: 1. What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery 2. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hallux Valgus Deformity, Hallux Valgus (Bunion) Resection, Hallux Valgus Surgery
- How many people
- 483 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Nov 2017to 31 Aug 2023
- How long will I take part?
- 12 Months
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients presenting to a private surgeon in Sydney, Australia
Who may be able to join
- Primary diagnosis of hallux valgus that has failed conservative treatment
Who cannot join
- Degenerative changes of first MTPJ
- Previous hallux valgus deformity correction surgery
Trial locations and contacts
1 site in 1 country.
Australia1 site
Orthopaedic and Arthritis Specialist Centre
Sydney, New South Wales
About this study
The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are:
- What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery
- What severity of bunion deformity can be corrected with minimally invasive surgery
- What factors may lead to recurrence of bunion deformity
- What is the rate of complications following bunion deformity surgery
Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.
- Conditions
- Hallux Valgus Deformity, Hallux Valgus (Bunion) Resection, Hallux Valgus Surgery, Hallux Deformity, Forefoot Surgery, Minimally Invasive Surgical Procedures
- Keywords
- Bunion, Hallux valgus, percutaneous surgery, minimally invasive surgery, forefoot deformity, metatarsal osteotomy, patient reported outcome measure, Manchester Oxford Foot Questionnaire (MOXFQ), Osteotomy, Observational Study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients | Consecutive patients aged 16 years and over, who had exhausted conservative treatment and subsequently underwent primary correction of hallux valgus (of any deformity severity) were included. Patients who underwent additional forefoot procedures eg. hammer toe corrections, distal metaphyseal metatarsal osteotomy, were included. Patients who had previously had hallux valgus surgery, or first ray degenerative joint disease were excluded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manchester-Oxford Foot Questionnaire (MOXFQ)
A validated patient reported outcome measure for assessment of function in hallux valgus.
The Manchester Oxford Foot Questionnaire (MOXFQ) consists of 3 domains (walking and standing, social interaction [based on the patient's self-consciousness regarding their feet/shoes as well as the overall impact on social, recreational, work, and other everyday activities], and pain), with the score in each domain ranging from 0 (best possible score) to 100 (worst possible score). An overall summary "index" score can also be calculated. The minimal clinically important difference (MCID) has been shown to be 16, 12, and 24 for the walking and standing, pain, and social interaction domains, respectively.
Measured: Patients completed the MOXFQ at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up.
Secondary outcomes (4)
Complication Data
Complication data were routinely prospective collected for all patients until discharge and categorised using a modified Clavien-Dindo complication classification.
Measured: Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications
EuroQol 5D Health Related Quality of Life (EQ-5D)
A validated patient reported outcome measure for health related quality of life. The EQ-5D is a standardized patient-reported outcome measure (PROM) assessing health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity, from no problems to extreme problems. The scores are combined into a health profile and converted into a single index value reflecting overall health, where 1 represents perfect health, 0 represents death, and negative values indicate health states worse than death. The EQ-5D also includes a visual analog scale (VAS) for patients to rate their overall health.
Measured: Patients completed the EQ5D at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).
Radiographic Deformity Correction
The intermetatarsal angle (IMA) and hallux valgus angle (HVA) were measured according to the American Orthopaedic Foot \& Ankle Society technique and categorised with regards to deformity severity. pre-operatively, six months following surgery and final follow up. Round sign and sesamoid coverage were classified according to Okuda et al. and Yildirim et al.
Measured: Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)
Visual Analogue Scale for Pain (VAS Pain)
A validated outcome measure to assess pain. The Visual Analog Scale (VAS) for pain consists of a straight line with one end labeled no pain(0) and the other worst possible pain(100). Patients mark a point on the line that represents their pain level, and the distance from the no pain end to the mark is measured to quantify the pain. Higher scores indicate greater pain intensity, with 0 being no pain and 100 being the worst imaginable pain.
Measured: Patients completed the VAS Pain at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Nov 2017
- Primary completion31 Jan 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus DeformityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 483 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Orthopaedic and Arthritis Specialist Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Lewis, Orthopaedic and Arthritis Specialist Centre
- Investigators
- Peter Lam, MBBS (Hons), FRACS,, Principal investigator, Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625229
- Sponsor's protocol ID
- PLHV2024
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient consent not discussed for sharing of IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
- ClinicalTrials.gov ID
- NCT06625229
- Acronym / sponsor ID
- PLHV2024
- Conditions
- Hallux Valgus Deformity, Hallux Valgus (Bunion) Resection, Hallux Valgus Surgery, Hallux Deformity, Forefoot Surgery, Minimally Invasive Surgical Procedures
- Keywords
- Bunion, Hallux valgus, percutaneous surgery, minimally invasive surgery, forefoot deformity, metatarsal osteotomy, patient reported outcome measure, Manchester Oxford Foot Questionnaire (MOXFQ)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Orthopaedic and Arthritis Specialist CentreUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Oct 2024 (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.
The goal of this observational study is to learn if percutaneous transverse osteotomies for hallux valgus deformity are safe and effective. The main questions it aims to answer are:
- What is the change in clinical patient reported outcome measures after minimally invasive bunion surgery
- What severity of bunion deformity can be corrected with minimally invasive surgery
- What factors may lead to recurrence of bunion deformity
- What is the rate of complications following bunion deformity surgery
Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients | – | –Consecutive patients aged 16 years and over, who had exhausted conservative treatment and subsequently underwent primary correction of hallux valgus (of any deformity severity) were included. Patients who underwent additional forefoot procedures eg. hammer toe corrections, distal metaphyseal metatarsal osteotomy, were included. Patients who had previously had hallux valgus surgery, or first ray degenerative joint disease were excluded. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients presenting to a private surgeon in Sydney, Australia
Key inclusion criteria (1 listed)
- Primary diagnosis of hallux valgus that has failed conservative treatment
Key exclusion criteria (2 listed)
- Degenerative changes of first MTPJ
- Previous hallux valgus deformity correction surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Manchester-Oxford Foot Questionnaire (MOXFQ)
Time frame: Patients completed the MOXFQ at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up.
A validated patient reported outcome measure for assessment of function in hallux valgus. The Manchester Oxford Foot Questionnaire (MOXFQ) consists of 3 domains (walking and standing, social interaction [based on the patient's self-consciousness regarding their feet/shoes as well as the overall impact on social, recreational, work, and other everyday activities], and pain), with the score in each domain ranging from 0 (best possible score) to 100 (worst possible score). An overall summary "index" score can also be calculated. The minimal clinically important difference (MCID) has been shown to be 16, 12, and 24 for the walking and standing, pain, and social interaction domains, respectively.
4 secondary outcomes
Complication Data
Time frame: Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications
EuroQol 5D Health Related Quality of Life (EQ-5D)
Time frame: Patients completed the EQ5D at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).
Radiographic Deformity Correction
Time frame: Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)
Visual Analogue Scale for Pain (VAS Pain)
Time frame: Patients completed the VAS Pain at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up(minimum 12 months following surgery).
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 3 Oct 2024.
- Individual participant dataSharing planned: No. Patient consent not discussed for sharing of IPD
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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.
Peter Lam, MBBS (Hons), FRACS, principal investigator
Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia
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 Deformity and Hallux Valgus (Bunion) Resection, run by Orthopaedic and Arthritis Specialist Centre at 1 site in Australia.
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 3 Oct 2024. 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 Australia. 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?
Manchester-Oxford Foot Questionnaire (MOXFQ) (time frame: Patients completed the MOXFQ at 6,12 and 24 months following surgery. Patients outside of these time points were asked to complete scores at their final follow up.). 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 3 Oct 2024.