Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06625229




Registration number
NCT06625229
Ethics application status
Date submitted
20/09/2024
Date registered
3/10/2024

Titles & IDs
Public title
Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
Scientific title
Fourth Generation Percutaneous Transverse Osteotomies for Hallux Valgus
Secondary ID [1] 0 0
PLHV2024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hallux Valgus Deformity 0 0
Hallux Valgus (Bunion) Resection 0 0
Hallux Valgus Surgery 0 0
Hallux Deformity 0 0
Forefoot Surgery 0 0
Minimally Invasive Surgical Procedures 0 0
Minimally Invasive Surgical Technique 0 0
Hallux Abductovalgus 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Manchester-Oxford Foot Questionnaire (MOXFQ)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
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 outcome [1] 0 0
Complication Data
Assessment method [1] 0 0
Complication data were routinely prospective collected for all patients until discharge and categorised using a modified Clavien-Dindo complication classification.
Timepoint [1] 0 0
Clinical notes were reviewed at final follow up (minimum 12 months post surgery) following surgery to assess for any complications
Secondary outcome [2] 0 0
EuroQol 5D Health Related Quality of Life (EQ-5D)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Radiographic Deformity Correction
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Specified timepoints during study (6weeks, 6months, final follow up (minimum 12 months following surgery)
Secondary outcome [4] 0 0
Visual Analogue Scale for Pain (VAS Pain)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
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).

Eligibility
Key inclusion criteria
* Primary diagnosis of hallux valgus that has failed conservative treatment
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Degenerative changes of first MTPJ
* Previous hallux valgus deformity correction surgery

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2023
Sample size
Target
Accrual to date
Final
483
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Orthopaedic and Arthritis Specialist Centre - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Orthopaedic and Arthritis Specialist Centre
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Peter Lam, MBBS (Hons), FRACS,
Address 0 0
Orthopaedic and Arthritis Specialist Centre, Chatswood, Sydney, Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06625229