An observational study in Hallux Valgus Deformity, Hallux Valgus (Bunion) Resection and Hallux Valgus Surgery, sponsored by Orthopaedic and Arthritis Specialist Centre. Completed at 1 site in Australia. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Orthopaedic and Arthritis Specialist Centre · Observational
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:
Researchers will retrospectively review a research registry containing prospectively collected clinical and radiographic deformity data collected as part of routine care.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's enrollment of 483 is above the median of 60 across 35 observational studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →This is the only study on the registry with Orthopaedic and Arthritis Specialist Centre as lead sponsor.
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Consecutive patients presenting to a private surgeon in Sydney, Australia
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Exclusion Criteria:
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.
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.
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.
Complication Data
Complication data were routinely prospective collected for all patients until discharge and categorised using a modified Clavien-Dindo complication classification.
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)
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.
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
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.
Time frame: 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.
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).
Plan to share: No — Patient consent not discussed for sharing of IPD
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jan 2023, 62 months.
Of 15 observational studies under Hallux Valgus, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 62. This study's 62 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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