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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)
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
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)
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
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)
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient consent not discussed for sharing of IPD


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